Panels › Microbiology › Product code MZO · Class 2
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Regulation 866.3169
2510(k)s in 12 months (3 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in MZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 2 | 1 |
| Abbott GmbH | 0 | 2 |
| Diasorin Inc. | 0 | 1 |
| Home Access Health Corp (HAHC) | 0 | 1 |
| OraSure Technologies, Inc. | 0 | 1 |
| ORTHO-CLINICAL DIAGNOSTICS | 0 | 1 |
| Roche Diagnostics | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2024 | Abbott GmbH Alinity i Anti-HCV Reagent Kit, List Number 08P0521 Open, Classified |
MZO | None listed |
| Apr 4, 2024 | Abbott GmbH ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 Open, Classified |
MZO | None listed |
| Jan 15, 2016 | OraSure Technologies, Inc. OraQuick HCV Visual Reference Panel
Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device. Terminated |
MZO | None listed |
| Sep 19, 2014 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- O Terminated |
MZO | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM Anti-HCV Reagent Pack; list 05C36; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MZO | None listed |
| Nov 4, 2006 | Home Access Health Corp (HAHC) Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an uni Terminated |
MZO | None listed |
| Oct 1, 2005 | Diasorin Inc. ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. Terminated |
MZO | None listed |
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