Identity
- Trade Name
- REMEL FDA UDI
- Generic Name
- Mueller-Hinton broth antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- MH Broth w/Cations (10ml) 20/PK FDA UDI
- Model / Reference
- R07128 FDA UDI
- Description
- MH Broth w/Cations (10ml) 20/PK FDA UDI
Identifiers
- Catalog Number
- R07128 FDA UDI
- Primary DI / UDI-DI
- 00848838011061 FDA UDI
- 510(k) Number
- K960313 FDA UDI
- FDA Product Code
- JTZ FDA UDI
- GMDN Term
- Mueller-Hinton broth antimicrobial susceptibility culture medium IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mueller-Hinton broth antimicrobial susceptibility culture medium IVD
Remel by Remel, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mueller-Hinton broth antimicrobial susceptibility culture medium IVD.
- BD Difco™ Mueller Hinton Broth — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Mueller Hinton II Broth (Cation-Adjusted) — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Mueller Hinton II Broth, Cation-Adjusted — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Mueller Hinton Broth — BECTON DICKINSON AND COMPANY · Class II
- BD Difco™ Mueller Hinton Broth — BECTON DICKINSON AND COMPANY · Class II
- T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC — REMEL, INC. · Class II
- REMEL — REMEL, INC. · Class II
- REMEL — REMEL, INC. · Class II
Cleared under the same submission
K960313 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Remel, Inc.
Sources (1)
- FDA UDI c70e99ef-5bc2-43a2-8bd0-11470cebf22a 35 fields · synced May 30, 2026