Identity
- Trade Name
- FLEX Mono Mo A-Hu Nucleophosmin Cl 376 RTU (Link) FDA UDI
- Generic Name
- Nucleophosmin (NPM1) antigen IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human Nucleophosmin Clone 376 Ready-to-Use (Link) FDA UDI
- Model / Reference
- IR652 FDA UDI
- Description
- FLEX Monoclonal Mouse Anti-Human Nucleophosmin Clone 376 Ready-to-Use (Link) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572030041 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Nucleophosmin (NPM1) antigen 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
Category: Nucleophosmin (NPM1) antigen IVD, antibody
FLEX Mono Mo A-Hu Nucleophosmin Cl 376 RTU (Link) by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Nucleophosmin (NPM1) antigen IVD, antibody.
- Tinto NPM1/B23, MMab — BIO SB, INC. · Class I
- NPM1/B23, MMab — BIO SB, INC. · Class I
- NPM1 — BIOCARE MEDICAL, LLC · Class I
- NPM1/B23, MMab — BIO SB, INC. · Class I
- NPM1 — BIOCARE MEDICAL, LLC · Class I
- NPM1 — BIOCARE MEDICAL, LLC · Class I
- NPM1 — BIOCARE MEDICAL, LLC · Class I
- Tinto NPM1/B23, MMab — BIO SB, 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
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 29dfe985-818a-4d47-afa2-e2075052371f 36 fields · synced Jun 6, 2026