Stains, Microbiologic
FDA product code JTS · Class I (low risk) · 21 CFR 864.1850 · Hematology
40510(k) clearances
0PMA approvals
8recalls
GMP exemptexempt from GMP rules
Manufacturers
- Remel Co. 12
- Alpha-Tec Systems, Inc. 5
- Accra Laboratories, Inc. 4
- Scientific Device Laboratory, Inc. 3
- Marion Laboratories, Inc. 2
- Devetec, Inc. 1
- Intl. Remote Imaging Systems 1
- Alpha-Tech Systems, Inc. 1
- Wescor, Inc. 1
- Scott Laboratories, Inc. 1
- Lakewood Biochemical Co., Inc. 1
- Difco Laboratories, Inc. 1
- Sigma Diagnostics, Inc. 1
- Reagent Laboratory, Inc. 1
- American Micro Scan 1
- Dms Laboratories 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Carr-Scarborough Microbiologicals, Inc. 1
- Bioscientific 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960095 | Bactidrop Calcofluor WhiteJTS · Traditional | Remel Co. | 03/19/1996SE |
| K960090 | Calcofluor White Stain KitJTS · Traditional | Remel Co. | 03/19/1996SE |
| K920976 | Bactidrop India InkJTS · Traditional | Remel Co. | 06/09/1992SE |
| K920975 | Bactidrop Calcofluor WhiteJTS · Traditional | Remel Co. | 06/09/1992SE |
| K920970 | Bactidrop Koh (10%)JTS · Traditional | Remel Co. | 06/09/1992SE |
| K893530 | Iristain Formula 2, Parts 1 and 2JTS · Traditional | Intl. Remote Imaging Systems | 06/13/1989SE |
| K890861 | Ats Dobell & O'Connor's IodineJTS · Traditional | Alpha-Tec Systems, Inc. | 03/23/1989SE |
| K890020 | Ats Lugol's Iodine SolutionJTS · Traditional | Alpha-Tec Systems, Inc. | 02/24/1989SE |
| K884069 | Snap N' Stain Iodine StainJTS · Traditional | Scientific Device Laboratory, Inc. | 10/25/1988SE |
| K883052 | Metheno-Stain KitJTS · Traditional | Scientific Device Laboratory, Inc. | 08/30/1988SE |
| K883061 | Ats Para-Set Carbol-Xylene SolutionJTS · Traditional | Alpha-Tech Systems, Inc. | 08/17/1988SE |
| K883049 | Ats Para-Set Iodine Alcohol SolutionJTS · Traditional | Alpha-Tec Systems, Inc. | 08/17/1988SE |
| K880989 | Ats Cryptosporidium Stain SetJTS · Traditional | Alpha-Tec Systems, Inc. | 05/13/1988SE |
| K881598 | SDL Trichrome StainJTS · Traditional | Scientific Device Laboratory, Inc. | 05/04/1988SE |
| K881512 | Wescor Gram Stain Pack for Model 7300 AerosprayJTS · Traditional | Wescor, Inc. | 04/18/1988SE |
| K881042 | Ats Trichrome Stain (Wheatley's Modification)JTS · Traditional | Alpha-Tec Systems, Inc. | 03/30/1988SE |
| K880718 | Calcofluor White Stain KitJTS · Traditional | Remel Co. | 03/25/1988SE |
| K874662 | Myco-Fluor Reagent a & BJTS · Traditional | Scott Laboratories, Inc. | 11/25/1987SE |
| K873413 | Gram Crystal Violet/Iodine/Aceton Alchl Declr/SafrJTS · Traditional | Lakewood Biochemical Co., Inc. | 10/06/1987SE |
| K872189 | Methanol, AbsoluteJTS · Traditional | Remel Co. | 07/29/1987SE |
| K872187 | TB Kinyoun CarbolfuchsinJTS · Traditional | Remel Co. | 07/29/1987SE |
| K872186 | Sulfuric Acid 10%JTS · Traditional | Remel Co. | 07/29/1987SE |
| K872185 | Light GreenJTS · Traditional | Remel Co. | 07/29/1987SE |
| K872184 | TB Methylene BlueJTS · Traditional | Remel Co. | 07/29/1987SE |
| K871606 | Spottest Flagella StainJTS · Traditional | Difco Laboratories, Inc. | 05/15/1987SE |
| K871532 | Tomtec Gram Stainer Crystal VioletJTS · Traditional | Remel Co. | 04/29/1987SE |
| K870988 | Price's Acid-Fast StainJTS · Traditional | Devetec, Inc. | 03/30/1987SE |
| K853896 | Gram Stain KitJTS · Traditional | Sigma Diagnostics, Inc. | 10/22/1985SE |
| K851494 | Two-Step Acid Fast Bacteria StainJTS · Traditional | Accra Laboratories, Inc. | 04/29/1985SE |
| K851493 | Kinyoun Acid Fast Stain KitJTS · Traditional | Accra Laboratories, Inc. | 04/29/1985SE |
| K843429 | Gram Stain Set W/Stabilized IodineJTS · Traditional | Accra Laboratories, Inc. | 09/14/1984SE |
| K843050 | Gram StainJTS · Traditional | Reagent Laboratory, Inc. | 09/11/1984SE |
| K831060 | Trichrome StainJTS · Traditional | American Micro Scan | 06/08/1983SE |
| K821038 | Fast Violet BJTS · Traditional | Dms Laboratories | 05/27/1982SE |
| K813369 | Gram Stain Reagents and KitJTS · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/22/1981SE |
| K812668 | Afb Stain SetJTS · Traditional | Carr-Scarborough Microbiologicals, Inc. | 09/29/1981SE |
| K811780 | Accra-Lab Gram Stain Set 55760JTS · Traditional | Accra Laboratories, Inc. | 07/27/1981SE |
| K781643 | Acid Fast KitJTS · Traditional | Bioscientific | 10/03/1978SE |
| K781061 | Droppers, Solution, IodineJTS · Traditional | Marion Laboratories, Inc. | 08/14/1978SE |
| K780346 | Mif Procedure KitJTS · Traditional | Marion Laboratories, Inc. | 03/22/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1296-2025 Class II | BD BBL TB Stain Kit K, Catalog (REF): 212522One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis… | Becton Dickinson & Co. | 02/12/2025Open, Classified |
| Z-2048-2020 Class II | BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of…May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci… | Becton Dickinson & Co. | 04/14/2020Terminated |
| Z-2047-2020 Class II | BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms…May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci… | Becton Dickinson & Co. | 04/14/2020Terminated |
| Z-2046-2020 Class II | BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms…May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci… | Becton Dickinson & Co. | 04/14/2020Terminated |
| Z-2171-2018 Class II | Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | BioMerieux SA | 03/23/2018Terminated |
| Z-0449-2015 Class II | Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg.…The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of… | Remel Inc | 10/29/2014Terminated |
| Z-2032-2012 Class II | Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits…Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small &… | Becton Dickinson & Co. | 04/12/2012Terminated |
| Z-2031-2012 Class II | BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional…Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small &… | Becton Dickinson & Co. | 04/12/2012Terminated |