Identity
- Trade Name
- Genemed® FDA UDI
- Generic Name
- Proliferating cell nuclear antigen (PCNA) IVD, antibody FDA UDI
- Device Name
- anti-PCNA Mouse Monoclonal Antibody [PC10], Concentrate, 1 mL FDA UDI
- Model / Reference
- 61-0054 FDA UDI
- Description
- anti-PCNA Mouse Monoclonal Antibody [PC10], Concentrate, 1 mL FDA UDI
Identifiers
- Catalog Number
- 61-0054 FDA UDI
- Primary DI / UDI-DI
- 00615233004598 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Proliferating cell nuclear antigen (PCNA) 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
Yes
FDA UDI
Category: Proliferating cell nuclear antigen (PCNA) IVD, antibody
Genemed® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Proliferating cell nuclear antigen (PCNA) IVD, antibody.
- Rabbit Monoclonal Anti-Human PCNA Antibody, EP91 — EPITOMICS, INC. · Class I
- PCNA [PC10] — BIOCARE MEDICAL, LLC · Class I
- Mono Mo A-Proliferating Cell Nuclear Antigen Cl PC10 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- IHC — Slmp, LLC · Class I
- ANTI-PCNA — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human PCNA Antibody, EP91 — EPITOMICS, INC. · Class I
- PCNA [PC10] — BIOCARE MEDICAL, LLC · Class I
- Anti-Human PCNA FITC Conjugate — LIFE TECHNOLOGIES LIMITED · 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
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI b2e2635e-a525-4069-9bbd-5bf67c89f5f8 35 fields · synced Jun 6, 2026