Identity
- Trade Name
- InTray® SMA FDA UDI
- Generic Name
- Sorbitol-MacConkey E. coli agar culture medium IVD FDA UDI
- Device Name
- a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar." FDA UDI
- Model / Reference
- 1423 FDA UDI
- Description
- a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar." FDA UDI
Identifiers
- Catalog Number
- 21-423-001 FDA UDI
- Primary DI / UDI-DI
- B08814230 FDA UDI
- FDA Product Code
- JSI FDA UDI
- GMDN Term
- Sorbitol-MacConkey E. coli agar culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2360 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: Sorbitol-MacConkey E. coli agar culture medium IVD
InTray® SMA by Biomed Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Biomed Diagnostics, Inc.
Sources (1)
- FDA UDI 3857cad3-0f13-407a-928d-104afe12d291 35 fields · synced May 31, 2026