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Phosphate Buffered Saline with Tween 20 (20X)
EUDAMEDFDA UDIClass A (EU MDR)
Ref R1031-500
Identity
- Trade Name
- Phosphate Buffered Saline with Tween 20 (20X) EUDAMEDFDA UDI
- Generic Name
- Buffered isotonic saline reagent IVD FDA UDI
- Device Name
- Phosphate Buffered Saline with Tween 20 (20X) EUDAMEDWashing buffer. Also aids in reagent spreading on tissue samples. FDA UDI
- Model / Reference
- R1031-500 EUDAMED1 FDA UDI
- Description
- Washing buffer. Also aids in reagent spreading on tissue samples. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030080 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R10315005N EUDAMED
- Direct Marketing DI
- 00850042030080 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
- Netherlands 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 with Tween 20 (20X) by Lumatas Biosystems, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0850042030R10315005N | 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 f8623777-8530-4493-b9de-65c82851f159 61 fields · synced Jul 9, 2026
- FDA UDI 4503f938-92a5-42a4-a854-305922475c7a 34 fields · synced May 29, 2026