Identity
- Trade Name
- RED COUNTERSTAIN II FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Model / Reference
- 05272017001 FDA UDI
Identifiers
- Catalog Number
- 05272017001 FDA UDI
- Primary DI / UDI-DI
- 04015630972043 FDA UDI
- FDA Product Code
- HZF FDA UDI
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1850 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: Biological stain IVD
Red Counterstain Ii by Ventana Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- REMEL — REMEL, INC. · Class I
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
- Ventana Medical Systems
Sources (1)
- FDA UDI 993621e6-b02e-45ed-a317-c9a2b6fe9420 33 fields · synced Jun 8, 2026