Identity
- Trade Name
- Mueller Hinton Agar II FDA UDI
- Generic Name
- Mueller-Hinton agar antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- (Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method. FDA UDI
- Model / Reference
- 0 FDA UDI
- Description
- (Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method. FDA UDI
Identifiers
- Catalog Number
- NCM0023C FDA UDI
- Primary DI / UDI-DI
- 00860003684627 FDA UDI
- 510(k) Number
- K811049 FDA UDI
- FDA Product Code
- JTZ FDA UDI
- GMDN Term
- Mueller-Hinton agar 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
Moist Heat or Steam Sterilization FDA UDI
Category: Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
Mueller Hinton Agar II by Neogen Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mueller-Hinton agar antimicrobial susceptibility culture medium IVD.
- MUELLER HINTON — Healthlink · Class II
- InTray® Mueller Hinton Chocolate Agar — Biomed Diagnostics, Inc. · Class I
- BD BBL™ Mueller Hinton II Agar — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Mueller Hinton II Agar — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Mueller Hinton II Agar — BECTON DICKINSON AND COMPANY · Class II
- BD Difco™ Mueller Hinton Agar — BECTON DICKINSON AND COMPANY · Class II
- MUELLER HINTON — Healthlink · Class II
- BD Difco™ Mueller Hinton Agar — BECTON DICKINSON AND COMPANY · Class II
Cleared under the same submission
K811049 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
- Neogen Corporation
Sources (1)
- FDA UDI 4aabb6c7-376a-49fa-8553-2052de53259f 37 fields · synced Jun 8, 2026