Supplement, Culture Media
FDA product code JSK · Class I (low risk) · 21 CFR 866.2450 · Microbiology
70510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Oxoid U.S.A., Inc. 30
- Acumedia Manufacturers, Inc. 10
- Gibco Laboratories Life Technologies, Inc. 7
- Pro-Lab, Inc. 7
- Flow Laboratories, Inc. 3
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Alpha-Tec Systems, Inc. 2
- Central Biological Co. 1
- Dutchland Laboratories, Inc. 1
- Kelco 1
- Remel Co. 1
- Bartels Immunodiagnostic Supplies, Inc. 1
- Roseville Medical Laboratoriesu 1
- Abbott Laboratories 1
- Micro-Bio-Logics 1
- Hazleton Research Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881949 | Ats Nac-Pac SetJSK · Traditional | Alpha-Tec Systems, Inc. | 05/25/1988SE |
| K881879 | Ats M/15 Phosphate Buffer, Product #034-42JSK · Traditional | Alpha-Tec Systems, Inc. | 05/13/1988SE |
| K881566 | Hemoglobin PowderJSK · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K861997 | Penicillin-Streptomycin-Fungizone MixtureJSK · Traditional | Hazleton Research Products, Inc. | 06/10/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K855172 | Kwi (TM) G-Co/TwoJSK · Traditional | Micro-Bio-Logics | 02/20/1986SE |
| K853546 | Abbott Cation Supplement SolutionJSK · Traditional | Abbott Laboratories | 09/06/1985SE |
| K850302 | Suplex & Suplex DiluentJSK · Traditional | Pro-Lab, Inc. | 03/22/1985SE |
| K850738 | Supplement for Culture MediumJSK · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
| K850308 | C.L.A.T.JSK · Traditional | Pro-Lab, Inc. | 03/20/1985SE |
| K850307 | Campylobacter Supplement-Blaser/WangJSK · Traditional | Pro-Lab, Inc. | 03/20/1985SE |
| K850306 | Campylobacter Supplement -SkirrowJSK · Traditional | Pro-Lab, Inc. | 03/20/1985SE |
| K850301 | Yeast DialysateJSK · Traditional | Pro-Lab, Inc. | 03/20/1985SE |
| K850300 | MucolyseJSK · Traditional | Pro-Lab, Inc. | 03/20/1985SE |
| K850299 | C.N.V.T.JSK · Traditional | Pro-Lab, Inc. | 03/20/1985SE |
| K840333 | Legionella Bmpa Selective SuppleJSK · Traditional | Oxoid U.S.A., Inc. | 05/11/1984SE |
| K840331 | Legionella Mwy Selective SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 05/11/1984SE |
| K840330 | Preston Campylobacter Selective SuppJSK · Traditional | Oxoid U.S.A., Inc. | 05/11/1984SE |
| K834115 | Cultrol-Antibiotic/Antimycotic SolutJSK · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 03/23/1984SE |
| K834066 | Tinsdale EnrichmentJSK · Traditional | Remel Co. | 01/04/1984SE |
| K833210 | LactoseJSK · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K833020 | Campylobacter Selective Supple-ButzlerJSK · Traditional | Gibco Laboratories Life Technologies, Inc. | 10/14/1983SE |
| K833019 | Campylobacter Selective Supple-BlaserJSK · Traditional | Gibco Laboratories Life Technologies, Inc. | 10/14/1983SE |
| K833018 | Campylobacter-Selective Supple-SkirrowJSK · Traditional | Gibco Laboratories Life Technologies, Inc. | 10/14/1983SE |
| K832902 | Middlebrook Adc EnrichmentJSK · Traditional | Gibco Laboratories Life Technologies, Inc. | 09/26/1983SE |
| K831469 | Legionella Cye Agar Base & Bcye SupplJSK · Traditional | Oxoid U.S.A., Inc. | 06/08/1983SE |
| K831219 | Clostridium Difficile Selective SuppleJSK · Traditional | Gibco Laboratories Life Technologies, Inc. | 05/13/1983SE |
| K820610 | GelriteJSK · Traditional | Kelco | 10/27/1982SE |
| K822511 | Yersinia Selective SupplementJSK · Traditional | Gibco Laboratories Life Technologies, Inc. | 09/14/1982SE |
| K822462 | G-N Anaerobe SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 09/14/1982SE |
| K822461 | N-S Anaerobe SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 09/14/1982SE |
| K822460 | Lcat Antibiotic SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 09/14/1982SE |
| K822459 | Vcat Antibiotic SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 09/14/1982SE |
| K822458 | Yeast Autolyxate SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 09/14/1982SE |
| K811732 | Thiotone PeptoneJSK · Traditional | Acumedia Manufacturers, Inc. | 07/02/1981SE |
| K811730 | BiosateJSK · Traditional | Acumedia Manufacturers, Inc. | 07/02/1981SE |
| K811653 | PhytoneJSK · Traditional | Acumedia Manufacturers, Inc. | 07/02/1981SE |
| K811652 | Polypeptone PeptoneJSK · Traditional | Acumedia Manufacturers, Inc. | 07/02/1981SE |
| K811649 | GelysateJSK · Traditional | Acumedia Manufacturers, Inc. | 07/02/1981SE |
| K811518 | VCNT Antibiotic SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 06/24/1981SE |
| K811517 | VCN SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 06/24/1981SE |
| K811516 | Legionella, Growth & Selective, Supp.JSK · Traditional | Oxoid U.S.A., Inc. | 06/24/1981SE |
| K811225 | Human Blood in Alsever'sJSK · Traditional | Dutchland Laboratories, Inc. | 06/12/1981SE |
| K811361 | Pancreatic Hydrolysate of Heart MuscleJSK · Traditional | Acumedia Manufacturers, Inc. | 05/29/1981SE |
| K811360 | Yeast ExtractJSK · Traditional | Acumedia Manufacturers, Inc. | 05/29/1981SE |
| K811357 | Hemoglobin PowderJSK · Traditional | Acumedia Manufacturers, Inc. | 05/29/1981SE |
| K810932 | VitoxJSK · Traditional | Oxoid U.S.A., Inc. | 04/14/1981SE |
| K810591 | Pact SupplementJSK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/20/1981SE |
| K802753 | Campylobacter Selective Supplement (Bl.)JSK · Traditional | Oxoid U.S.A., Inc. | 12/11/1980SE |
| K800267 | Campylobacter Selective SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800266 | Campylobacter Growth SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800265 | Bordetella Selective SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800264 | Chloramphenicol Antibiotic SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800263 | Perfringens Supplement BJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800262 | Perfringens Supplement aJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800261 | Dermasel SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800260 | Streptococcus SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800259 | Oxytetracycline Antibiotic SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800258 | Staphylococci/Streptococci SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800257 | Campylobacter Selective SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800256 | Tinsdale SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800255 | Sterile GC Supplement (W/O Antibiotics)JSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800254 | Mycoplasma Supplement PJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800253 | Mycoplasma Supplement GJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K800252 | Sterile GC SupplementJSK · Traditional | Oxoid U.S.A., Inc. | 03/12/1980SE |
| K790801 | Sterile Defibrinated Sheep BloodJSK · Traditional | Central Biological Co. | 05/03/1979SE |
| K780306 | Lyophilized Vials of Vca and VcatJSK · Traditional | Gibco Laboratories Life Technologies, Inc. | 03/17/1978SE |
| K760589 | Vca InhibitorJSK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/07/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2214-2017 Class III | Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and…Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with… | Acumedia Manufacturers, Inc. | 09/11/2015Terminated |
| Z-1232-2015 Class II | Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials.…Use of the product may not provide adequate recovery and could result in false negative identification of… | Remel Inc | 02/05/2015Terminated |
| Z-0578-2015 Class II | Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth…Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false… | Remel Inc | 11/13/2014Terminated |
| Z-0200-2015 Class II | Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A…Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may… | Remel Inc | 10/17/2014Terminated |
| Z-1112-2014 Class II | Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10…The product may contain high levels of microbial contamination | Remel Inc | 01/24/2014Terminated |
| Z-0801-2013 Class II | The product is a lyophilized growth supplement for use with dehydrated culture media to…The product may contain low level microbial contamination which could result in incorrect results. | Remel Inc | 10/10/2012Terminated |