Identity
- Trade Name
- Rabbit Monoclonal Anti-Human GCDFP-15 (EP95) FDA UDI
- Generic Name
- Gross cystic disease fluid protein-15 IVD, antibody FDA UDI
- Device Name
- Rabbit Monoclonal Anti-Human GCDFP-15 (EP95), concentrated FDA UDI
- Model / Reference
- AC-0085CMBULK FDA UDI
- Description
- Rabbit Monoclonal Anti-Human GCDFP-15 (EP95), concentrated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810138720110 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Gross cystic disease fluid protein-15 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
Category: Gross cystic disease fluid protein-15 IVD, antibody
Rabbit Monoclonal Anti-Human GCDFP-15 (EP95) by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gross cystic disease fluid protein-15 IVD, antibody.
- GCDFP-15 — BIOCARE MEDICAL, LLC · Class I
- A-1-Antitrypsin control slides — BIO SB, INC. · Class I
- GCDFP-15 RMab — BIO SB, INC. · Class I
- GCDFP-15 (23A3) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- GCDFP-15 (23A3) + Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal — CELL MARQUE CORPORATION · Class I
- GCDFP-15 (EP1582Y) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- GCDFP-15 — BIOCARE MEDICAL, LLC · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epitomics, Inc.
Sources (1)
- FDA UDI 9fc48332-3cd6-4cce-b771-b37c90101782 35 fields · synced May 29, 2026