Identity
- Trade Name
- Phosphate Buffered Saline EUDAMEDFDA UDI
- Generic Name
- Buffered isotonic saline reagent IVD FDA UDI
- Device Name
- Phosphate Buffered Saline EUDAMEDWashing buffer. Also aids in reagent spreading on tissue samples. FDA UDI
- Model / Reference
- R1032-052 EUDAMED1 FDA UDI
- Description
- Washing buffer. Also aids in reagent spreading on tissue samples. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030295 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R10320525P EUDAMED
- Direct Marketing DI
- 00850042030295 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Buffered isotonic saline reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Phosphate Buffered Saline by Lumatas Biosystems, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850042030R10320525P | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Lumatas BioSystems Inc
- EUDAMED SRN
- US-MF-000017316
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (2)
- EUDAMED ecb1fb6e-a72a-49e5-b7a8-7ca3e0f5ce5b 61 fields · synced Jun 18, 2026
- FDA UDI a2a8eb27-436b-4c70-ba14-d7696ba57ddf 34 fields · synced May 29, 2026