Panels › Microbiology › Product code JTO · Class 1
Discs, Strips And Reagents, Microorganism Differentiation
Regulation 866.2660
0510(k)s in 12 months (244 all time)
0recalls in 12 months (21 all time)
5recalls that name a 510(k)
Top companies in JTO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc API JAMES 2AMP, CATALOG 70542 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc API NIT1 NIT2 REAGENTS, CATALOG 70442 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc API VP1 VP2 REAGENTS, CATALOG 70422 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011 Open, Classified |
JTO | None listed |
| Jan 4, 2023 | Biomerieux Inc API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 Open, Classified |
JTO | None listed |
| Dec 1, 2021 | MEDLINE INDUSTRIES, LP - Northfield HARDY DIAGNOSTICS CatScreen, 25dsk/vial Terminated |
JTO | K960996 |
| Jul 1, 2021 | Gibson Bioscience Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145
Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydr Terminated |
JTO | None listed |
| Mar 23, 2018 | BioMerieux SA Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomo Terminated |
JTO | None listed |
| Dec 18, 2013 | Remel Inc Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartfor Terminated |
JTO | K842828 |
| Dec 18, 2013 | Remel Inc Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label Terminated |
JTO | K842828 |
| May 29, 2013 | Becton Dickinson & Co. BBL DrySlide Oxidase Kit, catalog number 231746
Product Usage:
Presumptive diagnostic aid for gram-negative bacteria. Terminated |
JTO | K896398 |
| May 29, 2013 | Becton Dickinson & Co. BBL DrySlide PYR Kit, catalog number 231747
Product Usage:
Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria. Terminated |
JTO | None listed |
| Mar 4, 2010 | Becton Dickinson & Co. BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled in part ***Methylene Blue Loeffler***Becton Dickinson and Company***Packaged in Terminated |
JTO | K842086 |
| Feb 24, 2004 | Hardy Media Inc Dba Hardy Diag Nitrate Reagent A, Cat No. Z71, Lot 3338
Nitrate Reagent B, Cat No. A72, Lot 3338 Terminated |
JTO | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.