100 Abbott Park Road Abbott Park, IL Trade Name: ARCHITECT HIV Ag/Ab Combo Assay Approved Date: 18-JUN-2010
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1 Currently Approved CBER Device Premarket Applications (PMAs) As of Nov 10, 2014 Sorted by Applicant Name BP BP BP BP BP BP BP BP Abbott Laboratories 100 Abbott Park Road Abbott Park, IL Trade Name: ARCHITECT HIV Ag/Ab Combo Assay Approved Date: 18-JUN-2010 Abbott Molecular, Inc E. Touhy Avenue Des Plaines, IL Trade Name: Abbott RealTime HIV-1 Amplification Reagent Kit Abbott RealTime HIV-1 Calibrator Kit Abbott RealTime HIV-1 Control Kit Approved Date: 11-MAY-2007 Approved Under ABBOTT Molecular, Inc. Alere Scarborough 10 Southgate Road Scarborough, ME Trade Name: Alere DetermineTM HIV-1/2 Ag/Ab Combo Approved Date: 08-AUG-2013 Avioq, Inc Great Seneca Hwy. Rockville, MD Trade Name: Avioq HIV-1 Microelisa System Approved Date: 21-SEP-2009 biolytical Laboratories, Inc Commerce Parkway Richmond, BC, British Columbia Canada V6V 2X7 Trade Name: INSTI HIV-1 Antibody Test Kit Approved Date: 29-NOV-2010 Trade Name: Multispot HIV-1/HIV-2 Rapid Test Approved Date: 12-NOV-2004 Approved Under Bio-Rad Laboratories Trade Name: GS HIV Combo Ag/Ab EIA Approved Date: 22-JUL-2011 Approved Under Bio-Rad Laboratories
2 Trade Name: Bio-Rad Geenius HIV 1/2 Supplemental Assay Approved Date: 24-OCT-2014 BP BP BP BP BP BP BP BP BioArray Solutions, Ltd. 35 Technology Drive Suite 100 Warren, NJ Trade Name: Immucor PreciseType Human Erythrocyte Antigen Molecular BeadChip Test Approved Date: 21-MAY-2014 Trade Name: Chembio HIV Reactive/Nonreactive Controls SURE CHECK HIV 1/2 ASSAY Approved Date: 25-MAY-2006 Trade Name: Chembio HIV Reactive/Nonreactive Controls HIV 1/2 STAT-PAK ASSAY Approved Date: 25-MAY-2006 Trade Name: DPP HIV 1/2 Assay Approved Date: 19-DEC-2012 Fenwal Inc Three Corporate Drive 2nd Floor Lake Zurich, IL Trade Name: Autopheresis-C Plasmapheresis System Approved Date: 24-MAR-1986 Approved Under Baxter Healthcare Corporation Home Access Health Corporation 2401 West Hassell Road Suite 1510 Hoffman Estates, IL Trade Name: Home Access HIV-1 Test System Approved Date: 22-JUL-1996 Maxim Biomedical Inc 1440 Fourth Street Berkeley, CA Trade Name: Calypte HIV-1 Urine EIA Approved Date: 12-JAN-2001 Approved Under Calypte Biomedical Corporation Maxim Biomedical Inc
3 1265 Harbor Bay Parkway Alameda, CA Trade Name: Cambridge Biotech HIV-1 Urine Western Blot Approved Date: 21-JUN-2001 Approved Under Calypte Biomedical Corporation BP BP BP BP BP BP MedMira Labs 155 Chain Lake Drive, Bayers Lake Halifax, Nova Scotia Canada B3S 1B3 Trade Name: MedMira Rapid HIV Test Approved Date: 16-APR SW Creekside Place Beaverton, OR Trade Name: Orasure HIV-1 Oral Specimen Collection Device Approved Date: 23-DEC-1994 Approved Under OraSure Technologies 220 East First Street Bethlehem, PA Trade Name: OraSure HIV-1 Western Blot Kit Approved Date: 03-JUN-1996 Approved Under Epitope, Inc. 150 Webster Street Bethlehem, PA Trade Name: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Approved Date: 07-NOV-2002 Approved Under OraSure Technologies 220 East First Street Bethlehem, PA Trade Name: OraQuick In-Home HIV Test Approved Date: 03-JUL-2012 Organogenesis, Inc. 150 Dan Road Canton, MA Trade Name: Apligraf Approved Date: 22-MAY-1998 BP Organogenesis, Inc. 150 Dan Road Canton, MA Trade Name: Dermagraft Approved Date: 28-SEP-2001 BP Ortec International, Inc.
4 3960 Broadway, 2nd Floor New Yoir, NY Trade Name: Orcel Approved Date: 31-AUG-2001 BP BP BP BP Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY Trade Name: VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack Approved Date: 27-MAR-2008 Roche Molecular Systems, Inc US Highway 202 Branchburg, Somerville, NJ Trade Name: Roche Amplicor HIV-1 Monitor (tm) Test Approved Date: 03-JUN-1996 Roche Molecular Systems, Inc Hacienda Drive P.O. Box 9002 Pleasanton,, CA Trade Name: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L Approved Date: 11-MAY-2007 Shire Regenerative Medicine, Inc Torreyana Road San Diego, CA Trade Name: Dermagraft-TC (temporary covering) Approved Date: 18-MAR-1997 BP BP BP Siemens Healthcare Diagnostics 511 Benedict Ave. Tarrytown, NY Trade Name: ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents Approved Date: 18-MAY-2006 Approved Under Bayer HealthCare Siemens Medical Solutions Diagnostics P.O. Box 2466 Berkeley, CA Trade Name: Quntiplex HIV-1 RNA 3.0 Assay (bdna) Approved Date: 11-SEP-2002 Approved Under Bayer Corporation Thermogenesis 2711 Citrus Road
5 Rancho Cordova, CA Trade Name: CryoSeal FS System Approved Date: 26-JUL-2007 BP Trinity Biotech IDA Business Park Southern Cross Road, Bray, Co. Wicklow Ireland Trade Name: Uni-Gold Recombigen HIV-1 Approved Date: 23-DEC-2003 Approved Under Trinity Biotech plc
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For further information about this list including pricing, contact by Sensitivity: 99%
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Dry Needling (DN) Registration To register for any of our programs, please complete the enclosed registration form (next page) and mail of fax the form to us. Fees Cost of the DN 1-3 courses is US $895
Blood Screening Assays. CTS lab locations where assays are performed are indicated by alpha codes D, P, and T.
Blood Screening Assays CTS lab locations where assays are performed are indicated by alpha codes D, P, and T. D= performed in Dallas lab FEI: 3002580251 P= performed in Phoenix lab FEI: 3000204058 T= performed