chromID MRSA
by Biomerieux, Inc. 2 variants
510(k) K162076
chromID MRSA is a Class II device made by Biomerieux, Inc., cleared under FDA 510(k) K162076 on 25 Oct 2016, active as of 10 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162076 | Date25 Oct 2016 | StatusActive |
Official records
- FDA 510(k) database K162076
Recalls
-
- Ongoing Z-0802-2023
- Ongoing Z-0842-2023
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Timeline
- Cleared FDA 510(k) K162076
- Recall initiated FDA recalls Z-0802-2023
- Recall initiated FDA recalls Z-0842-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JSO
- Device class
- Class II
- Regulation
- 21 CFR Part 866.1700
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K162076
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CHROMID® MRSA / CHROMID S. aureus | CHROMID® MRSA / CHROMID S. aureus | 03573026552091 | — | On the market |
Similar devices
Other devices filed under FDA product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar).
- GC II AGAR WITH ISOVITALEX by Becton Dickinson Microbiology Systems
- GCII AGAR WITH ISOVITALX(R) ENRICHMENT by Becton Dickinson Microbiology Systems
- BBLCHROMAGAR MRSA by BECTON, DICKINSON & CO.
- BRAIN HEART INFUSION AGAR by Carr-Scarborough Microbiologicals, Inc.
- HardyCHROM ESBL by HARDY DIAGNOSTICS
- HARDYCHROM MRSA by HARDY DIAGNOSTICS
- SPECTRA MRSA by Thermo Fisher Scientific
- WILKENS CHALGREN AGAR by Acumedia Manufacturers, Inc.
- MRSASELECT - EXTENDED INCUBATION by Bio-Rad
- HAEMOPHILUS TEST MEDIUM (HTM) by Clinical Standards Laboratories, Inc.