Identity
- Trade Name
- SALINE SOLUTION FDA UDI
- Generic Name
- Saline suspension medium/diluent IVD FDA UDI
- Device Name
- Saline Solution is a diluent used for manual preparation of organism suspensions, prior to identification and antimicrobial susceptibility processing with VITEK® 2 instruments. FDA UDI
- Model / Reference
- SALINE SOLUTION FDA UDI
- Description
- Saline Solution is a diluent used for manual preparation of organism suspensions, prior to identification and antimicrobial susceptibility processing with VITEK® 2 instruments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026617936 FDA UDI
- FDA Product Code
- LTW FDA UDILON FDA UDI
- GMDN Term
- Saline suspension medium/diluent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI866.1645 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Saline suspension medium/diluent IVD
Saline Solution by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Saline suspension medium/diluent IVD.
- Saline Solution (0.85%) — Biomed Diagnostics, Inc. · Class I
- KOLPLAST — Kolplast CI SA · Class I
- VITEK® 2 0, 45% Sodium Chloride Diluent — BIOMERIEUX , INC. · Class II
- SALINE SOLUTION — BIOMERIEUX , INC. · Class II
Cleared under the same submission
N50510 also covers:
- SMART CARRIER STATION — BIOMERIEUX , INC.
- VITEK — BIOMERIEUX , INC.
- VITEK® 2 AST-GN48 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN66 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN68 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN69 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN70 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN72 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN73 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN74 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN75 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN76 — BIOMERIEUX , INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI 46172ad0-dded-45f6-a42b-ad52992b14b0 35 fields · synced May 30, 2026