Identity
- Trade Name
- Immunocare PBS 10X FDA UDI
- Generic Name
- Immunohistochemistry wash buffer reagent IVD FDA UDI
- Model / Reference
- PWB941M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627014559 FDA UDI
- FDA Product Code
- JCC FDA UDI
- GMDN Term
- Immunohistochemistry wash buffer reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Immunohistochemistry wash buffer reagent IVD
Immunocare PBS 10X by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (2)
- FDA UDI 75e2d68b-fe64-4471-8e38-f232a879b479 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026