Panels › Hematology › Product code JTS · Class 1
Stains, Microbiologic
Regulation 864.1850
0510(k)s in 12 months (40 all time)
0recalls in 12 months (9 all time)
0recalls that name a 510(k)
Top companies in JTS
| Company | 510(k)s | Recalls |
|---|---|---|
| Remel Co. | 12 | 1 |
| Becton Dickinson & Co. | 0 | 7 |
| Alpha-Tec Systems, Inc. | 5 | 0 |
| Accra Laboratories, Inc. | 4 | 0 |
| Scientific Device Laboratory, Inc. | 3 | 0 |
| Marion Laboratories, Inc. | 2 | 0 |
| Alpha-Tech Systems, Inc. | 1 | 0 |
| American Micro Scan | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| BioMerieux SA | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2025 | Becton Dickinson & Co. BD BBL TB Stain Kit K, Catalog (REF): 212522 Open, Classified |
JTS | None listed |
| Apr 14, 2020 | Becton Dickinson & Co. BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms fr Terminated |
JTS | None listed |
| Apr 14, 2020 | Becton Dickinson & Co. BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures o Terminated |
JTS | None listed |
| Apr 14, 2020 | Becton Dickinson & Co. BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures Terminated |
JTS | None listed |
| Mar 23, 2018 | BioMerieux SA Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method.
Dye and chemical solution stains for medical Terminated |
JTS | None listed |
| Nov 25, 2014 | Remel Inc Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg.
A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycoba Terminated |
JTS | None listed |
| Jul 18, 2012 | Becton Dickinson & Co. Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles.
Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. Terminated |
JTS | None listed |
| Jul 18, 2012 | Becton Dickinson & Co. BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin.
Gram Stain Kits and Reagents are used to st Terminated |
JTS | None listed |
| Oct 20, 2004 | Becton Dickinson & Co. Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent. Terminated |
JTS | None listed |
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