Identity
- Trade Name
- CINtec Histology FDA UDI
- Generic Name
- p16 antigen IVD, antibody FDA UDI
- Model / Reference
- 06680011001 FDA UDI
Identifiers
- Catalog Number
- 06680011001 FDA UDI
- Primary DI / UDI-DI
- 04015630970476 FDA UDI
- 510(k) Number
- DEN160019 FDA UDI
- FDA Product Code
- PRB FDA UDI
- GMDN Term
- p16 antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.1865 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
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: p16 antigen IVD, antibody
CINtec Histology by Ventana Medical Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as p16 antigen IVD, antibody.
- ANTI-P16(INK4) — Biogenex Laboratories, Inc. · Class I
- ANTI-P16(INK4) — Biogenex Laboratories, Inc. · Class I
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- p16 INK4a [BC42] — BIOCARE MEDICAL, LLC · Class I
- p16 INK4a [BC42] — BIOCARE MEDICAL, LLC · Class I
- Mouse Monoclonal Anti-Human P16(MX007) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
Cleared under the same submission
DEN160019 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA UDI 6e036554-fc2b-48ed-8a8a-01c6e393987b 34 fields · synced May 30, 2026