Identity
- Trade Name
- SALINE SOLUTION EUDAMEDFDA UDI
- Generic Name
- Saline suspension medium/diluent IVD FDA UDI
- Device Name
- SALINE SOLUTION EUDAMEDSaline 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
- 542737 EUDAMEDSALINE 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
- 03573026617950 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000916U6 EUDAMED
- FDA Product Code
- LON FDA UDILTW FDA UDI
- EMDN Code
- W0203010185 ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Saline suspension medium/diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1645 FDA UDI866.1640 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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 — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- SALINE SOLUTION — BIOMERIEUX , INC. · Class II
- VITEK® 2 0, 45% Sodium Chloride Diluent — BIOMERIEUX , INC. · Class II
Cleared under the same submission
N50510 also covers:
- SALINE SOLUTION — BIOMERIEUX , INC.
- 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.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 528c4711-96bb-4fa4-a532-6fbb0b1f53a4 35 fields · synced Jul 31, 2026
- EUDAMED 867a4570-c5bf-40fd-800e-38dc373146cc 61 fields · synced Jul 31, 2026