Panels › Microbiology › Product code LLH · Class 1
Reagents, Clostridium Difficile Toxin
Regulation 866.2660
0510(k)s in 12 months (42 all time)
0recalls in 12 months (11 all time)
8recalls that name a 510(k)
Top companies in LLH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2021 | bioMerieux, Inc. VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 Open, Classified |
LLH | None listed |
| Jan 17, 2014 | Becton Dickinson & Co. BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5 Terminated |
LLH | K081920 |
| Oct 17, 2013 | Sekisui Diagnostics LLC Product Name: OSOM C. Difficile Toxin A/B Test
Catalog Numbers: 173 (for United States) and 173 E (for Europe).
The Test is a qualitative assay (in vitro diagnostic) that employs
immunochromatographi Terminated |
LLH | K102242 |
| Feb 12, 2013 | Remel Inc Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640.
Product Usage:
The test kit is a rapid in vitro immunochromatographic test for the direct, qual Terminated |
LLH | None listed |
| Feb 12, 2013 | Remel Inc Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650.
Product Usage: Usage:
The test kit is a rapid in vitro immunochromatographic test for the dir Terminated |
LLH | None listed |
| Sep 6, 2012 | Becton Dickinson & Co. BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***
BD GeneOhm Cdiff Assay Terminated |
LLH | K081920 |
| Sep 6, 2012 | Becton Dickinson & Co. BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***
BD GeneOhm Cdiff Assay is a qualitative i Terminated |
LLH | K081920 |
| Sep 6, 2012 | Becton Dickinson & Co. BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***
BD GeneOhm MRSA ACP Assay is a Terminated |
LLH | K093346 |
| Aug 5, 2010 | Becton Dickinson & Co. BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5***
Intended for use as an aid in diagnosis of CDAD. Terminated |
LLH | K081920 |
| Jul 4, 2006 | Meridian Bioscience Inc ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic. Terminated |
LLH | K041003 |
| Oct 24, 2003 | Meridian Bioscience Inc Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096. Terminated |
LLH | K993914 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.