Panels › Microbiology › Product code LIB · Class 1
Device, General Purpose, Microbiology, Diagnostic
Regulation 866.2660
0510(k)s in 12 months (43 all time)
1recalls in 12 months (13 all time)
0recalls that name a 510(k)
Top companies in LIB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | Becton Dickinson & Co. BD Kiestra" Isolate Suspension Cuvette Array;
Catalog No.: 246100; Open, Classified |
LIB | None listed |
| Feb 4, 2016 | BioMerieux SA API ZYM Bx2 (Ref 70493)
Product Usage:
ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips. Terminated |
LIB | None listed |
| Dec 16, 2014 | Remel Inc Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible fi Terminated |
LIB | None listed |
| Dec 16, 2014 | Remel Inc Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 13019 Terminated |
LIB | None listed |
| Apr 18, 2014 | BioMerieux SA API Listeria (REF 10300).
ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that e Terminated |
LIB | None listed |
| Apr 18, 2014 | BioMerieux SA API NIH (REF 10400).
ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enabl Terminated |
LIB | None listed |
| Apr 18, 2014 | BioMerieux SA FB Reagent (REF 70562).
FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips prod Terminated |
LIB | None listed |
| Apr 18, 2014 | BioMerieux SA ZYM B Reagent (REF 70493).
The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized Terminated |
LIB | None listed |
| Apr 18, 2014 | Remel Inc Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The respon Terminated |
LIB | None listed |
| Apr 18, 2014 | Remel Inc Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible fi Terminated |
LIB | None listed |
| Mar 12, 2014 | Biomerieux Inc bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO. Terminated |
LIB | None listed |
| May 14, 2008 | Remel Inc Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Remel, Lenexa, KS 66215 Terminated |
LIB | None listed |
| May 14, 2008 | Remel Inc Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Remel, Lenexa, KS 66215 Terminated |
LIB | None listed |
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