DECLARATION OF CONFORMITY
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- Iris Byrd
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1 Declaration of Conformity DECLARATION OF CONFORMITY 1) Manufacturer (Name, department): Goldenbio Technologies, Corp. Address: 1326 Monte Vista Ave. Suite 4 Upland, CA and 2) European authorized representative: CEpartner4U BV, Address: ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS; (on product labels printed as: CEpartner4U, ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS. 3) Product(s) (name, type or model/batch, etc.): - ELISA, CLIA, RAPID, Controls see appendix Document ref.: DoC2016 vs. 00 Page: 1 of 25 4) The product(s) described above is in conformity with: Title In vitro Diagnostic Medical Devices Directive Document No. 98/79/EC 5) Additional information (Conformity procedure, Notified Body, CE certificate, Registration nr., etc.): Conformity assessment procedure for CE marking: In vitro Diagnostic Medical Device Directive, Annex III Registration nr. : NL-CA , NL-CA , NL-CA , NL-CA , NL-CA , NL-CA , NL-CA , NL-CA , CA , CA , CA Upland, USA, 2016/01/04 Bruce Ben: President, Golden Bio Technologies Corp
2 Appendix Date: Device name ALLERGY ELISA KITS Allergen Specific IgA GBE Allergen Specific IgE GBE Allergen Specific IgG GBE Allergen Specific IgM GBE IgE GBE Total Human IgA GBE Total Human IgE GBE Total Human IgG GBE Total Human IgM GBE ANEMIA ELISA KITS Ferritin GBE Folate GBE stfr-soluble Transferrin Soluble Receptor GBE Vitamin B12 GBE AUTOIMMUNE DISEASES ELISA KITS ANA Screen ELISA GBE ANA Comprehensive profile GBE Acetylcholin Receptor (AChR) Ab GBE Amyloid Beta Auto-Ab GBE Anti- Asialoglycoprotein Receptor (ASGPR) GBE See EDMS codes: (products classification)/preference GMDN code
3 GBE-2215 Anti Cyclic Citrullinated Peptide (CCP) Anti- Glomerular Basement GBE-2216 Membrane (GBM) Anti- Glutamic Acid Decarboxylase GBE-2217 (GAD) Anti- Liver Cytosol (LC-1) GBE Anti- Liver kidney Microsomal type 1 GBE-2219 (LKM-1) Anti-Alpha-Fodrin GBE Anti-Annexin V IgG/IgM GBE Anti-Bactericidal Permeability (BPI) GBE Anti-Cardiolipin IgA GBE Anti- Cardiolipin IgG GBE Anti- Cardiolipin IgM GBE Anti-Cardiolipin IgG/IgM GBE Anti-Cardiolipin IgG,IgA,IgM GBE Anti-Cathepsin G GBE Anti-Centromer B GBE Anti-dsDNA IgA GBE Anti-dsDNA IgG GBE Anti-dsDNA IgM GBE Anti-dsDNA Screen GBE Anti-Elastase GBE Anti-Histone GBE Anti-Insulin Ab GBE Anti-Jo-1 IgG GBE Anti-Lactoferrin GBE Anti-Lysozyme GBE Anti-MPO (p-anca) GBE Anti-Ovarian Ab GBE Anti-Phosphatidic Acid IgG/IgM GBE Anti-Phosphatidyl Inositol IgG/IgM GBE
4 Anti-Phosphatidyl Serine IgG/IgM GBE Anti-PR-3 (c-anca) GBE Anti-Prothrombin IgA GBE Anti-Prothrombin IgG/IgM GBE Anti-Prothrombin Screen GBE Anti-RNP/Sm GBE Anti-RNP-70 Kd GBE Anti-Saccharomyces cerevisiae GBE-2251 (ASCA) IgA Anti-Saccharomyces cerevisiae GBE-2252 (ASCA) IgG Anti-Scl-70 Kd GBE Anti-Sm GBE Anti-SS-A (Ro) GBE Anti-SS-A 52 GBE Anti-SS-A 60 GBE Anti-SS-B (La) GBE Anti-ssDNA GBE Anti-Nucleosomes (SLE) GBE Anti Tissue Transglutaminase IgA GBE Anti Tissue Transglutaminase IgG GBE Anti-Phospholipid GBE Beta 2 Glycoprotein 1 IgA GBE Beta 2 Glycoprotein 1 IgG GBE Beta 2 Glycoprotein 1 IgM GBE Beta2 Glycoprotein I IgG/IgM GBE Beta2 Glycoprotein I Screen( GBE IgG/IgM/IgA) Carbonylprotein GBE Cartilage Oligomeric Matrix Protein GBE-2270 (Human) ENA Combined Screen(6Ag) GBE-2271 Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS- B
5 ENA Profile (12 test kits) Sm/RNP, GBE Sm, Jo-1, Scl-70, SS-A, SS- B ENA-4-Profile GBE Gliadin IgA GBE Gliadin IgG GBE Gliadin Screen GBE Intrinsic Factor GBE Isle-Cell Autoantibody (ICA 2) GBE Screen Isle-Cell Autoantibody (ICA) GBE Mitochondria GBE Ribosomal P GBE Rheumatoid Factor IgA GBE Rheumatoid Factor IgG GBE Rheumatoid Factor IgM GBE Rheumatoid Factor Screen GBE Sperm Antibody (seminal fluid) GBE Thyroglobulin IgG GBE Thyroglobulin (Tg) GBE Thyroid Peroxidase (TPO) GBE TSH Receptor Autoantibody (2nd generation) TSH Receptor Autoantibody (3rd generation) GBE-2290 GBE-2291 BONE METABOLISM ELISA KITS Intact PTH GBE Vitamin D GBE CANCER ELISA KITS AFP (Alpha Fetoprotein) GBE Beta 2 Microglobulin GBE CA-125 GBE
6 CA-15-3 GBE CA-19-9 GBE CEA GBE CEA Next Generation GBE Free Beta HCG GBE NSE GBE Prostatic Acid Phosphatase (PAP) GBE CARDIAC ELISA KITS MARKERS CRP High Sensitive (hs-crp) GBE CRP GBE CKMB GBE Digoxin GBE LP(a) GBE Myoglobin GBE Troponin I (ctni) GBE DIABETES ELISA KITS C-Peptide GBE Insulin GBE Insulin Rapid GBE LEPTIN GBE FERTILITY ELISA KITS Beta HCG (Total) GBE FSH GBE HCG GBE HCG rapid GBE HGH GBE Prolactin (PRL) GBE PRL SEQUENTIAL GBE
7 INFECTIOUS DISEASES ELISA KITS Adenovirus IgA GBE Adenovirus IgG GBE Adenovirus IgM GBE Bordetella Pertussis IgA GBE Bordetella Pertussis IgG GBE Bordetella Pertussis IgM GBE Brucella IgA GBE Brucella IgG GBE Brucella IgM GBE Diphtheria GBE Diphtheria GBE EBV, EA-D IgG GBE EBV, EBNA IgG GBE EBV, VCA IgA GBE EBV, VCA IgG GBE EBV, VCA IgM GBE H. Pylori IgA GBE H. Pylori IgG GBE H. Pylori IgM GBE H. pylori Antigen GBE HAV IgG GBE HAV IgM GBE HDV IgM GBE HSV1,2 IgG GBE HSV1,2 IgM GBE HSV2 IgA GBE HSV2 IgG GBE HSV2 IgM GBE HSV1 IgA GBE HSV1 IgG GBE
8 HSV1 IgM GBE HEV Ab GBE HEV IgG GBE HEV IgM GBE HGV Ab GBE Influenza A IgA GBE Influenza A IgG GBE Influenza A IgM GBE Influenza B IgA GBE Influenza B IgG GBE Influenza B IgM GBE Legionella GBE IgG/IgM/IgA Legionella Urinary Antigen (Urine) GBE Leptospira IgM GBE Lyme Disease IgG GBE Lyme Disease IgG, IgM GBE Lyme Disease IgM GBE Measles IgG GBE Measles IgM GBE Mumps IgG GBE Mumps IgM GBE Mycobacterium Tuberculosis (TB) IgA GBE Mycobacterium Tuberculosis GBE-2565 (TB) IgG Mycobacterium Tuberculosis (TB) IgM GBE Mycoplasma pneumonia IgG GBE Mycoplasma pneumonia IgM GBE Rotavirus (Fecal) GBE RSV IgA GBE
9 RSV IgG GBE RSV IgM GBE Scrub Typhus IgG GBE Scrub Typhus IgM GBE Syphilis (TPA) IgG GBE Syphilis (TPA) IgG/IgM GBE Syphilis (TPA) IgM GBE Tetanus GBE VZV IgG GBE VZV IgM GBE PARASITOLOGY ELISA KITS Adenovirus (Fecal) GBE Campylobacter (Fecal) GBE Chagas IgG GBE Crypto/Giardia Ag Combo GBE Cryptosporidium (Fecal) GBE Cysticercosis (T. solium) GBE Dengue IgG GBE Dengue IgG/IgM GBE Dengue IgM GBE Dengue NS1 GBE E. histolytica (Amebiasis) GBE E. histolytica/dispar GBE E.coli O157 (Fecal) GBE E.coli Verotoxin (Fecal) GBE Echinococcus GBE Fasciola IgG GBE Giardia GBE Japanese Encephalitis IgG GBE Japanese Encephalitis IgM GBE Leishmania GBE
10 Leptospira IgG GBE Schistosoma IgG GBE Strongyloides GBE Toxocara IgG GBE Trichinella GBE West Nile IgG GBE West Nile IgM GBE STEROID ELISA KITS 17OHP GBE Androstenedione GBE Coritsol GBE DHEA GBE DHEA-S GBE Dihydro-Testosterone GBE E1 ( Estrone) GBE E2 ( Estradiol) GBE Free Estriol GBE Free Testosterone GBE Progesterone GBE SHBG GBE Testosterone GBE ue3 GBE THYROID ELISA KITS Free T3 GBE Free T4 GBE NT4 (Neonatal T4) GBE NTBG (Neonatal TBG) GBE NTSH (Neonatal TSH) GBE T3 SBS GBE
11 T3 Ultra Sensitive GBE T4 SBS GBE TBG GBE TSH GBE TSH Rapid GBE TSH Ultra Sensitive GBE T3 GBE T4 GBE T-Uptake GBE OTHER ELISA KITS Anti-Tetanus Toxoid GBE Diphtheria Toxoid IgG GBE HAMA GBE Lipase Quantitative GBE Micro-Albumin GBE Zeta Globin (Alpha-Thalassemia) GBE CHEMILUMINESCENCE IMMUNOASSAY ALLERGY CLIA KITS IgE CLIA GBL ANEMIA KITS CLIA KITS Floate CLIA GBL Ferritin GBL stfr-soluble Transferrin Soluble GBL Receptor CLIA Vitamin B12 CLIA GBL CARDIAC MARKERS CLIA KITS
12 CKMB CLIA GBL CTnI CLIA GBL DIG CLIA GBL hs-crp CLIA GBL Myoglobin CLIA GBL DIABETES CLIA KITS C-peptide CLIA GBL Insulin CLIA GBL Insuin Rapid CLIA GBL FERTILITY CLIA KITS β hcg GBL FSH CLIA GBL HGH GBL HCG CLIA GBL HCG Visual GBL LH CLIA GBL PRL Sequential CLIA GBL Prolactin (Serum) CLIA GBL INFECTIOUS DISEASES CLIA KITS EBV, EA-D IgG GBL EBV, EBNA IgG GBL EBV, VCA IgA GBL EBV, VCA IgG GBL EBV, VCA IgM GBL H.pylori IgA CLIA GBL H.pylori IgG CLIA GBL H.pylori IgM CLIA GBL H.pylori Antigen GBL HSV1 IgA GBL
13 HSV1 IgG CLIA GBL HSV1 IgM CLIA GBL HSV2 IgA GBL HSV2 IgG CLIA GBL HSV2 IgM CLIA GBL HSV1,2 IgG GBL HSV1,2 IgM GBL Measles IgG GBL Measles IgM GBL Mumps IgG GBL Mumps IgM GBL VZV IgG GBL VZV IgM GBL STEROID CLIA KITS Aldosterone CLIA GBL OHP CLIA GBL Coritsol CLIA GBL DHEA CLIA GBL DHEA-S CLIA GBL Estradiol CLIA GBL Estrone (Saliva) CLIA GBL Estrone (Serum) CLIA GBL Free Estriol (Saliva) CLIA GBL Free testosterone CLIA GBL Progesterone CLIA GBL Testosterone (Saliva)CLIA GBL Testosterone CLIA GBL ue3 CLIA GBL THYROID CLIA KITS Free T3 CLIA GBL
14 Device name Free T4 CLIA GBL Neonatal TSH GBL T3 SBS CLIA GBL T4 SBS CLIA GBL TSH Rappid CLIA GBL TBG CLIA GBL T3 CLIA GBL T4 CLIA GBL T3U CLIA GBL TSH CLIA GBL Ultra Sensitive TSH GBL TUMOR MARKER CLIA KITS AFP CLIA GBL Beta 2 Microglobulin CLIA GBL CEA Next Generation CLIA GBL CEA CLIA GBL CA 72-4 CLIA GBL CA-153 CLIA GBL CA-199 CLIA GBL CA-125 CLIA GBL CYFRA 21-1 CLIA GBL Free Beta hcg CLIA GBL NSE CLIA GBL RAPID TESTS Allergy Rapid Tests Casein GBR Gluten GBR IgE GBR Peanut GBR
15 Cancer Rapid tests AFP Serum (Cassette) GBR AFP Serum (Strip 5mm) GBR AFP Device (Whole GBR Blood/Serum/Plasma) CEA Serum (Strip 5mm) GBR Bladder Cancer Cassette GBR Fecal Occult Blood Rapid Test GBR-3215 (Cassette) Fecal Occult Blood Rapid Test (Strip) GBR Fecal Occult Blood Multi-Windows Rapid Test Strip GBR Cardiac markers Rapid tests Cardiac Markers Combo Device (Whole Blood/Serum/Plasma) Cardiac Troponin I Device (Whole Blood/Serum/Plasma) C-Reactive Protein Device (Whole Blood/Serum/Plasma) C-Reactive Protein Strip (Whole Blood/Serum/Plasma) CK-MB Device (Whole Blood/Serum/Plasma) Myoglobin Device (Whole Blood/Serum/Plasma) Myoglobin Cassette (Serum/Whole Blood) 3 in 1 Troponin I/Myoglobin/CK-MB Serum Rapid Test GBR-3310 GBR-3311 GBR-3312 GBR-3313 GBR-3314 GBR-3315 GBR-3316 GBR Drug Rapid tests Amphetamine Test (Cassette) GBR Amphetamine Test Strip GBR (BAR) Barbiturates Test Cassette GBR (BAR) Barbiturates Test Strip GBR
16 Device name (BNZ) Benzodiazepine Test Cassette GBR (BNZ) Benzodiazepine Test Strip GBR (BUP) Buprenorphine Test Cassette GBR (BUP) Buprenorphine Test Strip GBR (COC) Cocaine Test Cassette GBR (COC) Cocaine Test Strip GBR Cotinine Test Strip (Urine) GBR Cotinine Test Device (Urine) GBR Ecstasy (MDMA) Test Strip GBR EDDP Test Device (Urine) GBR EDDP Test Strip (Urine) GBR Fentanyl Test Cassette GBR Fentanyl Test Strip GBR K2/Spice drug test Strip GBR Ketamine Drug Test Cassette GBR Ketamine Drug Test Strip GBR Methamphetamine Test Device GBR Methamphetamine Test Strip GBR Morphine Test Device GBR Morphine Test Strip GBR Multiple Drugs Test Cup GBR Methaqualone Test Device GBR Methaqualone Test Strip GBR Methylphenidate (MPD) Drug Test GBR Cassette Methylphenidate (MPD) Drug Test GBR strip (MDMA) Ecstasy Test Cassette GBR (MDMA) Ecstasy Test Strip GBR (MTD) Methadone Test Cassette GBR (MTD) Methadone Test Strip GBR (OXY) Oxycodone Test Cassette GBR (OXY) Oxycodone Test Strip GBR
17 Device name Propoxyphene Test Device GBR Propoxyphene Test Strip GBR (PCP) Phencyclidine Test Cassette GBR (PCP) Phencyclidine Test Strip GBR Rapid Alcohol Test Strip GBR Rapid Alcohol Test Strip (Saliva) GBR (TCA) Tricyclic Antidepressants Test GBR-3451 Cassette (TCA) Tricyclic Antidepressants Test GBR-3452 Strip Tramadol Drug Test Cassette GBR Tramadol Drug Test Strip GBR THC Cassette GBR TML Cassette GBR Panel Drug Test Cassette (Any GBR Combination) 2-Panel Drug Test Strip (Any GBR Combination) 2-Panel Test (Any Combination) + GBR Alcohol (Strip) 2-Panel Test Cassette (MOR-MET) GBR Panel Test (Strip) (MOR,MET) GBR Panel Test (Strip) (BAR,BZD) GBR Panel Test (Strip) (BZD,MOR) GBR Panel Test (Strip) (COC,MOR) GBR Panel Test (Strip) (MAD,MOR) GBR Panel Test (Strip) (MET,THC) GBR Panel Test (Strip) (MOR,THC) GBR Panel Test (Cassette) (Any GBR Combination) 3-Panel Test (Any Combination) + GBR Alcohol (Strip) 3-Panel Test (Strip) GBR (AMP,MOR,THC) 3-Panel Test (Strip) GBR (AMP,COC,THC)
18 Device name 3-Panel Test (Strip) (BAR,BZD,PCP) GBR Panel Test (Strip) (BAR,MAD,PCP) GBR Panel Test (Strip) GBR (BZD,MAD,MOR) 3-Panel Test (Strip) GBR (COC,MOR,THC) 3-Panel Test (Strip) GBR (MET,MOR,THC) 3-Panel Test (MOR/mAMP/AMP) GBR Panel Test (Strip) (Any Drug GBR Combination) 4-Panel Test (Any combination) + GBR Alcohol (Strip) 4-Panel Test (Cassette) GBR (AMP,COC,MOR,THC) 4-Panel Test (Cassette) GBR (MET,MOR,THC,COC) 4-Panel Test (Strip) GBR (AMP,BAR,COC,THC) 4-Panel Test (Strip) GBR (AMP,BZD,COC,THC) 4-Panel Test (Strip) GBR (AMP,BZD,MET,THC) 4-Panel Test (Strip) GBR (AMP,COC,MET,THC) 4-Panel Test (Strip) GBR (BAR,BZD,MOR,PCP) 4-Panel Test (Strip) GBR (BZD,COC,MOR,THC) 4-Panel Test (Strip) GBR (COC,MOR,PCP,THC) 4-Panel Test (Strip) GBR (COC,MET,MOR,THC) 4-Panel Test GBR (MOR/THC/AMP/mAMP) 5-Panel Test Cassette (Any Drug GBR Combination) 5-Panel Test (Any combination) + GBR Alcohol (Strip)
19 5-Panel Test (Cup) (AMP,BZD,COC,OPI,THC) 5-Panel Test (Cup) (AMP,BZD,MET,OPI,THC) 5-Panel Test (Cup) (AMP,COC,THC,OPI,PCP) 5-Panel Test (Cup) (TCA,BUP,EDDP,OXY,THC) 5-Panel Test (Strip) (AMP,BAR,BZD,MOR,THC) 5-Panel Test (Strip) (AMP,BZD,COC,MAD,MOR) 5-Panel Test (Strip) (AMP,BZD,COC,MOR,MET) 5-Panel Test (Strip) (AMP,BZD,COC,MOR,THC) 5-Panel Test (Strip) (AMP,COC,MET,MOR,THC) 5-Panel Test (Strip) (BAR,COC,MET,MOR,THC) 5-Panel Test (Strip) (BZD,MAD,MET,MOR,THC) 5-Panel Test (Strip) (COC,MET,MOR,PCP,THC) 5-Panel Test (Strip) RapiDip TM InstaTest (BZD,MET,MOR,PCP,THC) 5-Panel Test (Strip) (THC,PCP,MOR,COC,AMP) 5-Panel Test (MOR/THC/AMP/mAMP/KET) 6-Panel Test Cassette ( Any combination) 6-Panel Test (Any combination) + Alcohol (Strip) 6-Panel Test (Strip) (AMP,BAR,COC,MET,MOR,THC) 6-Panel Test (Cassette) (AMP,BAR,BZD,COC,MET,THC) 6-Panel Test (Cassette) (MAD,MOR,THC,AMP,COC,BZD) GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR
20 6-Panel Test (Cassette) (MET,MOR,THC,AMP,COC,BZD) (Drug Test) 6-Panel Test (Cup) (AMP,BAR,COC,OPI,PCP,THC) 6-Panel Test (Strip) (BAR,BZD,COC,MAD,MOR,THC) 6-Panel Test (Strip) (AMP,BAR,BZD,COC,MOR,THC) 6-Panel Test (Strip) (AMP,BAR,BZD,COC,MET,MOR) 6-Panel Test (Strip) (AMP,BZD,COC,MET,MAD,MOR) 6-Panel Test (Strip) (AMP,COC,MET,MOR,PCP,THC) 6-Panel Test (Strip) (BZD,COC,MAD,MET,MOR,THC) 6-Panel Test (Strip) (MAD,MOR,THC,AMP,COC,BZD) 6-Panel Test (Strip) (MET,MOR,THC,AMP,COC,BZD) 6-Panel Test (MOR/THC/AMP/mAMP/COC/MD MA) 7-Panel Test (Cassette) (Any Drug Combination) 7-Panel Test (Strip) (Any Drug Combination) 7-Panel Test (Any combination) + Alcohol (Strip) 8-Panel Test (Strip) (Any Drug Combination) 8-Panel Test (Any combination) + Alcohol (Strip) 9-Panel Test (Strip) (Any Drug Combination) 9-Panel Test (Any combination) + Alcohol (Strip) 10-Panel Test (MOR/THC/AMP/mAMP/COC/PCP/ BZO/BAR/MDMA/MTD) GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR GBR
21 Infectious Disease & other Rapid tests Adenovirus Test Device (Feces) GBR Adenovirus Test Strip (Feces) GBR Chagas Antibody Test GBR Dengue (IgG/IgM) GBR Dengue NS1 GBR D-Dimer Cassette GBR EBV EA IgA Test GBR EBV EA IgG Test GBR EBV EA IgM Test GBR EBV EBNA IgA Test GBR EBV EBNA IgG Test GBR EBV EBNA IgM Test GBR ETG Cassette GBR ETG Strip GBR Gonorrhea Rapid Test (Cassette) GBR-3629 (Swab Test) Gonorrhea Rapid Test (Strip) GBR H. pylori Antibodies Rapid Test Strip GBR-3631 (Serum/Plasma) H. pylori Antibodies Rapid Test GBR-3632 Device (Serum/Plasma) H. pylori Antibodies Rapid Test GBR-3633 Device (Whole Blood/Serum/Plasma) H. pylori Antibodies Rapid Test Strip GBR-3634 (Whole Blood/Serum/Plasma) H. pylori Antigens Rapid Test Strip ( GBR-3635 Feces) HSV1 IgG Single Test GBR HSV1 IgM Single Test GBR HSV1 IgG and IgM 2 in 1 Combo GBR Test HSV2 IgG Single Test GBR
22 HSV2 IgM single Test GBR HSV2 IgG and IgM 2 in 1 Combo GBR Test Hb-Hp Cassette GBR Hemoglobin Guaiac Test GBR HPV16 Ab Cassette GBR IGFBP-1 Strip GBR Inflammatory Bowel Disease ( IBD) GBR Test Influenza A/B Rapid Test Strip GBR Influenza A/B Rapid Test Device GBR (Whole Blood/Serum/Plasma) Legionella Rapid Test (Cassette) GBR Leishmania Rapid Test (Strip) GBR Liver Fluke Antibody Test GBR Mononucleosis Serum Rapid Test GBR-3652 (Cassette) (Serum) Malaria Pf(HRP-II)/Pv(PLDH) Rapid GBR-3653 Test Malaria Pf(HRP-II)/PAN(PLDH) GBR-3654 Rapid Test Malaria Pf(HRP-II) (WB) Rapid Test GBR Malaria Pan(PLDH) (WB) Rapid Test GBR Malaria (P.flanP.) Combo Rapid Test GBR-3657 Device Microalbumin Strip GBR Rotavirus and adenovirus Combo GBR-3669 Rapid Test Strip (Feces) Rotavirus and adenovirus Combo GBR-3660 Rapid Test Device (Feces) Rotavirus Rapid Test Device (Feces) GBR Rotavirus Rapid Test Strip (Feces) GBR Salmonella Rapid Test GBR Schistosoma Antibody Test GBR Strep A Rapid Test Device (Swab) GBR Strep A Rapid Test Strip (Swab) GBR
23 Strep B Cassette GBR Syphilis Rapid Test Device (Whole GBR-3671 Blood/Serum/Plasma) Syphilis Rapid Test Device GBR-3672 (Serum/Plasma) Syphilis Rapid Test Strip GBR-3673 (Serum/Plasma) Syphilis Rapid Test Strip (Whole GBR-3674 Blood/Serum/Plasma) Tuberculosis Rapid Test Device GBR-3679 (Whole Blood/Serum/Plasma) Tuberculosis Rapid Test Strip (Whole GBR-3680 Blood/Serum/Plasma) Fertility/ Pregnancy Rapid tests FSH Urine Rapid Test (Strip) GBR FSH Urine Rapid Test (Cassette) GBR HCG (Human Chorionic GBR-3713 Gonadotropin) Strip (Urine) HCG (Human Chorionic GBR-3714 Gonadotropin) Device (Urine) HCG (Human Chorionic GBR-3715 Gonadotropin) Midstream (Urine) HCG (Human Chorionic GBR-3716 Gonadotropin) Strip (Urine/Serum) HCG (Human Chorionic GBR-3717 Gonadotropin) Device (Urine/Serum) Ovulation Rapid tests LH (Human Luteinizing Hormone) Strip (Urine) LH (Human Luteinizing Hormone) Device (Urine) LH (Human Luteinizing Hormone) Midstream (Urine) GBR-3811 GBR-3812 GBR Urine Reagent Strips tests Blood GBU
24 Glucose GBU Ketone GBU Protein GBU Glucose Protein GBU Glucose Protein ph GBU Glucose Protein ph Blood GBU Glucose Protein ph SG GBU Glucose Protein ph - Blood GBU Ketone Glucose Protein ph - Blood GBU Ketone - Bilirubin Glucose Protein ph - Blood GBU Urobilinogen Glucose - Protein ph Blood- GBU Urobilinogen Ketone Bilirubin Nitrite SG Leukocytes Glucose Protein - Blood Ketone Leukocyte - Bilirubin GBU Glucose Protein ph - GBU Urobilinogen Blood Ketone Bilirubin Urobilinogen Blood Ketone GBU Glucose Protein ph Bilirubin Nitrite SG Urobilinogen Blood Ketone GBU Glucose Protein ph Bilirubin Nitrite URS-11 (Urobilinogen/Blood/Ketone GBU /Glucose/ Protein/ ph/ Bilirubin/ Nitrite/SG/Leukocytes/Ascorbic Acid Urinestrip 3 GBU Urinestrip 7 GBU Urinestrip 10 GBU SEROLOGY TEST ASO Latex Test Kit GBS CRP Latex Test Kit GBS
25 Mono Test Kit GBS RF Latex Test Kit GBS RPR Test Kit GBS SLE Latex Test GBS Serum Control(BIO-RUN) Serocheck Chemistry Control (I) GBQ Serocheck Chemistry Control (II) GBQ Serocheck Immunoassay Plus Control GBQ-7721 (A) Serocheck Immunoassay Plus Control GBQ-7722 (B) Serocheck Immunoassay Plus Control GBQ-7723 (C) 30213
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