Identity
- Trade Name
- ProSpecT Microplate Assay Wash Buffer FDA UDI
- Generic Name
- Escherichia coli antigen IVD, reagent FDA UDI
- Model / Reference
- R2450002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501949 FDA UDI
- 510(k) Number
- K980507 FDA UDI
- FDA Product Code
- GMZ FDA UDI
- GMDN Term
- Escherichia coli antigen IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3255 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
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: Escherichia coli antigen IVD, reagent
ProSpecT Microplate Assay Wash Buffer by Remel Europe Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Escherichia coli antigen IVD, reagent.
Cleared under the same submission
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
- Remel Europe Limited
Sources (1)
- FDA UDI 7249c4f8-0cda-4655-9216-003b47a6603c 34 fields · synced Jun 1, 2026