Identity
- Trade Name
- InTray® XLT4 FDA UDI
- Generic Name
- Salmonella/Shigella species agar culture medium IVD FDA UDI
- Device Name
- A medium devised for selection of non-typhi Salmonella from samples contaminated with fecal matter. Growth of other organisms is inhibited and Salmonella can be differentiated from other organisms by colony color. FDA UDI
- Model / Reference
- 1493 FDA UDI
- Description
- A medium devised for selection of non-typhi Salmonella from samples contaminated with fecal matter. Growth of other organisms is inhibited and Salmonella can be differentiated from other organisms by colony color. FDA UDI
Identifiers
- Catalog Number
- 21-493-001 FDA UDI
- Primary DI / UDI-DI
- B08814930 FDA UDI
- FDA Product Code
- JSI FDA UDI
- GMDN Term
- Salmonella/Shigella species 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: Salmonella/Shigella species agar culture medium IVD
InTray® XLT4 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 cee8501c-da97-47f5-9369-6233127dd504 35 fields · synced Jun 1, 2026