Identity
- Trade Name
- Novocastra™ FDA UDI
- Generic Name
- Prostate-specific membrane antigen (PSMA) IVD, antibody FDA UDI
- Device Name
- NCL-L-PSA-431 is intended for the qualitative identification by light microscopy of human prostate specific antigen in paraffin sections. FDA UDI
- Model / Reference
- PSA-431-L-CE FDA UDI
- Description
- NCL-L-PSA-431 is intended for the qualitative identification by light microscopy of human prostate specific antigen in paraffin sections. FDA UDI
Identifiers
- Catalog Number
- NCL-L-PSA-431 FDA UDI
- Primary DI / UDI-DI
- 05055331325723 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
Yes
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
No
FDA UDI
Category: Prostate-specific membrane antigen (PSMA) IVD, antibody
Novocastra™ by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prostate-specific membrane antigen (PSMA) IVD, antibody.
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- Mouse Monoclonal Anti-Human PSMA(MX095) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Rabbit Monoclonal Anti-Human PSMA Antibody, EP192 — EPITOMICS, INC. · 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
- Rabbit Monoclonal Anti-Human PSMA Antibody, EP192 — EPITOMICS, INC. · 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
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 44489644-48db-4e95-9886-7aec6c27bf99 36 fields · synced May 31, 2026