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Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJ
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJ FDA UDI
- Generic Name
- Prostatic acid phosphatase (PAP) IVD, antibody FDA UDI
- Device Name
- Monoclonal Mouse Anti-Human Prostatic Acid Phosphatase Clone PASE/4LJ FDA UDI
- Model / Reference
- M0792 FDA UDI
- Description
- Monoclonal Mouse Anti-Human Prostatic Acid Phosphatase Clone PASE/4LJ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572005599 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Prostatic acid phosphatase (PAP) 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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Prostatic acid phosphatase (PAP) IVD, antibody
Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJ by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Prostatic acid phosphatase (PAP) IVD, antibody.
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- PSAP (RBT-PSAP) — BIO SB, INC. · Class I
- PSAP (PASE/4LJ) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- BOND™ — Leica Biosystems Newcastle, 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
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 6cefd86c-d5a8-4617-8507-d12c0a2c157a 37 fields · synced Jun 1, 2026