Identity
- Trade Name
- REMEL FDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- Selenite Broth w/Cystine (9ml) 100/PK FDA UDI
- Model / Reference
- R064506 FDA UDI
- Description
- Selenite Broth w/Cystine (9ml) 100/PK FDA UDI
Identifiers
- Catalog Number
- R064506 FDA UDI
- Primary DI / UDI-DI
- 00848838009761 FDA UDI
- FDA Product Code
- JSD FDA UDI
- GMDN Term
- Differential/selective broth 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
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
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: Differential/selective broth culture medium IVD
This selenite broth w/cystine (9ml) 100/pk device is used for microbiological testing and has been published in 2023-01-02. It is marketed by REMEL, INC.
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Also classified as Differential/selective broth culture medium IVD.
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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
- Remel, Inc.
Sources (1)
- FDA UDI b9abbaae-7715-4c31-abda-dd5684ecc518 34 fields · synced Jul 11, 2026