ARCHITECT ANTI-HCV
FDA premarket approval P050042/S002 · decided 2007-03-05
Approval details
- PMA number
- P050042
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ARCHITECT ANTI-HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2007-01-11
- Decision date
- 2007-03-05
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO EXTEND THE EXPIRATION DATING OF REAGENTS, CALIBRATORS, AND CONTROLS TO 14 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT ANTI-HCV AND IS INDICATED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 (K090358) | Abbott Laboratories, Inc. | 2009-08-06 |
| CREATININE (K061193) | Abbott Laboratories, Inc. | 2006-06-23 |
| PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS (K051213) | Abbott Laboratories, Inc. | 2005-05-27 |
| FOX PLUS PTA CATHETER (K040954) | Abbott Laboratories, Inc. | 2004-05-11 |
| AXSYM CYCLOSPORINE (K040761) | Abbott Laboratories, Inc. | 2004-04-30 |
| GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT (K023062) | Abbott Laboratories, Inc. | 2002-09-30 |