Identity
- Trade Name
- ANTI-CYTOKERATIN 7 FDA UDI
- Generic Name
- Multiple solid tumour differentiation marker IVD, antibody FDA UDI
- Model / Reference
- AX255-YCD FDA UDI
Identifiers
- Catalog Number
- AX255-YCD FDA UDI
- Primary DI / UDI-DI
- 00810119676511 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Multiple solid tumour differentiation marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
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: Multiple solid tumour differentiation marker IVD, antibody
Anti-Cytokeratin 7 by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple solid tumour differentiation marker IVD, antibody.
- Melanoma Cocktail — BIOCARE MEDICAL, LLC · Class I
- TTF-1 + Napsin A (RM) — BIOCARE MEDICAL, LLC · Class I
- TTF-1 + Napsin A — BIOCARE MEDICAL, LLC · Class I
- Desmoglein 3 + Napsin A — BIOCARE MEDICAL, LLC · Class I
- p16 + Ki-67 — BIOCARE MEDICAL, LLC · Class I
- NeoPATH Pro Universal Negative Control Serum — BIOCARE MEDICAL, LLC · Class I
- Pan Melanoma Cocktail-2 — BIOCARE MEDICAL, LLC · Class I
- Pan Melanoma Cocktail-2 — BIOCARE MEDICAL, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI a166da19-5dbc-4e31-b688-8c4c4a154f6b 34 fields · synced Jun 8, 2026