Identity
- Trade Name
- Rabbit Monoclonal Anti-Human PSMA Antibody, EP192 FDA UDI
- Generic Name
- Prostate-specific membrane antigen (PSMA) IVD, antibody FDA UDI
- Device Name
- Rabbit Monoclonal Anti-Human PSMA (192), 1 mL concentrated FDA UDI
- Model / Reference
- AC-0160 FDA UDI
- Description
- Rabbit Monoclonal Anti-Human PSMA (192), 1 mL concentrated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113064260 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Prostate-specific membrane antigen (PSMA) 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: Prostate-specific membrane antigen (PSMA) IVD, antibody
Rabbit Monoclonal Anti-Human PSMA Antibody, EP192 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prostate-specific membrane antigen (PSMA) IVD, antibody.
- Mouse Monoclonal Anti-Human PSMA(MX095) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Mouse Monoclonal Anti-Human PSMA(MX095) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- CONFIRM® anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody — Ventana Medical Systems · Class I
- Mouse Monoclonal Anti-Human PSMA(MX095) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- PSMA (EP192) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- PSMA (EP192) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · 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 6d5a40af-5617-440b-bb53-66c3d6c47409 36 fields · synced Jun 8, 2026