Panels › Microbiology › Product code LKQ · Class 2
Antibody Igm,If, Cytomegalovirus Virus
Regulation 866.3175
0510(k)s in 12 months (18 all time)
0recalls in 12 months (8 all time)
5recalls that name a 510(k)
Top companies in LKQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 1 | 2 |
| Abbott Laboratories | 1 | 1 |
| Biomerieux Inc | 0 | 2 |
| Immuno Concepts, Inc. | 2 | 0 |
| QIAGEN Gaithersburg, Inc. | 0 | 2 |
| Whittaker Bioproducts, Inc. | 2 | 0 |
| Baxter Diagnostics, Inc. | 1 | 0 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Boston Biomedica, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2022 | bioMerieux, Inc. VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. Terminated |
LKQ | K933549 |
| Mar 16, 2021 | Biomerieux Inc VIDAS CMV IgM 30 Tests Terminated |
LKQ | K933549 |
| Aug 30, 2016 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), S Terminated |
LKQ | K100433 |
| Aug 30, 2016 | Siemens Healthcare Diagnostics, Inc. IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 ( Terminated |
LKQ | K100433 |
| May 14, 2013 | QIAGEN Gaithersburg, Inc. QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223)
Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using r Terminated |
LKQ | None listed |
| May 14, 2013 | QIAGEN Gaithersburg, Inc. QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225)
Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in hou Terminated |
LKQ | None listed |
| Jan 23, 2012 | Quest International, Inc. SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Terminated |
LKQ | K982485 |
| Jul 11, 2007 | Abbott Laboratories AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LKQ | None listed |
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