Identity
- Trade Name
- CINtec PLUS Cytology FDA UDI
- Generic Name
- Ki67 antigen IVD, kit, enzyme immunohistochemistry FDA UDI
- Model / Reference
- 100 test FDA UDI
Identifiers
- Catalog Number
- 07478496001 FDA UDI
- Primary DI / UDI-DI
- 04015630977215 FDA UDI
- PMA Number
- P190024 FDA UDI
- GMDN Term
- Ki67 antigen IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- 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
Yes
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, antibodyKi67 antigen IVD, kit, enzyme immunohistochemistry
CINtec PLUS Cytology by Ventana Medical Systems — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ki67 antigen IVD, kit, enzyme immunohistochemistry.
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- ihcDirect® Ki67 Ab Conjugate 5mL — NOVODIAX, INC. · Class I
- Ki-67 IHC MIB-1 pharmDx (Dako Omnis) — Agilent Technologies Inc. · Class III
- Q-STAIN® QSX-Enh-F Ki67 — NOVODIAX, INC. · Class I
- ihcDirect® Ki67Ab Conjugate 15mL — NOVODIAX, 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA UDI 20aeac07-2b3c-409e-836a-ea5b639d7a27 34 fields · synced Jun 8, 2026