Identity
- Trade Name
- InPouch® TV FDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples. FDA UDI
- Model / Reference
- 1031 FDA UDI
- Description
- Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples. FDA UDI
Identifiers
- Catalog Number
- 21-031-001 FDA UDI
- Primary DI / UDI-DI
- B08810310 FDA UDI
- 510(k) Number
- K896296 FDA UDI
- FDA Product Code
- JSN FDA UDI
- GMDN Term
- Differential/selective broth culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 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
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: Differential/selective broth culture medium IVD
InPouch® TV by Biomed Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 bc2a11ca-9c0c-4a6d-912e-95e0037a0859 37 fields · synced Jun 8, 2026