Identity
- Trade Name
- Saline Solution (0.85%) FDA UDI
- Generic Name
- Saline suspension medium/diluent IVD FDA UDI
- Device Name
- Saline Solution (0.85%) is a saline solution for viral specimens. FDA UDI
- Model / Reference
- 1612 FDA UDI
- Description
- Saline Solution (0.85%) is a saline solution for viral specimens. FDA UDI
Identifiers
- Catalog Number
- 11-612-001 FDA UDI
- Primary DI / UDI-DI
- B08816120 FDA UDI
- FDA Product Code
- JSG FDA UDI
- GMDN Term
- Saline suspension medium/diluent 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: Saline suspension medium/diluent IVD
Saline Solution (0.85%) by Biomed Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Saline suspension medium/diluent IVD.
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- SALINE SOLUTION — BIOMERIEUX , INC. · Class II
- VITEK® 2 0, 45% Sodium Chloride Diluent — BIOMERIEUX , INC. · Class II
- SALINE SOLUTION — BIOMERIEUX , INC. · 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 |
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Manufacturer
- Manufacturer
- Biomed Diagnostics, Inc.
Sources (1)
- FDA UDI 43e96a2f-6d14-426e-b57b-7197a286d9f9 35 fields · synced May 30, 2026