Identity
- Trade Name
- InTray® Mueller Hinton Chocolate Agar FDA UDI
- Generic Name
- Mueller-Hinton agar antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C. FDA UDI
- Model / Reference
- 2483 FDA UDI
- Description
- Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C. FDA UDI
Identifiers
- Catalog Number
- 22-483-001 FDA UDI
- Primary DI / UDI-DI
- B08824830 FDA UDI
- FDA Product Code
- JSG FDA UDI
- GMDN Term
- Mueller-Hinton agar antimicrobial susceptibility culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
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 agar antimicrobial susceptibility culture medium IVD
InTray® Mueller Hinton Chocolate Agar by Biomed Diagnostics, Inc. — Class I — 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
- BD BBL™ Mueller Hinton II Agar — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Mueller Hinton II Agar — BECTON DICKINSON AND COMPANY · Class II
- Mueller Hinton Agar II — NEOGEN CORPORATION · Class II
- Mueller Hinton Agar II — NEOGEN CORPORATION · 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
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomed Diagnostics, Inc.
Sources (1)
- FDA UDI d00ea085-7b13-4a76-b77a-90d43952336f 34 fields · synced May 30, 2026