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Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183 FDA UDI
- Generic Name
- P57 protein IVD, antibody FDA UDI
- Device Name
- Rabbit Monoclonal Anti-Human p57/Kip2 (183), 1 mL concentrated FDA UDI
- Model / Reference
- AC-0205 FDA UDI
- Description
- Rabbit Monoclonal Anti-Human p57/Kip2 (183), 1 mL concentrated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113065168 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- P57 protein 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: P57 protein IVD, antibody
Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as P57 protein IVD, antibody.
- p57/Kip2 (Kp10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- p57/Kip2 (Kp10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- p57/Kip2 (Kp10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- p57/Kip2 (Kp10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- p57/Kip2 (Kp10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183 — EPITOMICS, 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
- Epitomics, Inc.
Sources (1)
- FDA UDI b9f5d75b-3f80-4b5f-82f8-1ff27d5cbe37 36 fields · synced May 30, 2026