← Back to catalogue

FLEX Mono Mo A-Hu Nucleophosmin Cl 376 RTU (Dako Omnis)

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name
FLEX Mono Mo A-Hu Nucleophosmin Cl 376 RTU (Dako Omnis) FDA UDI
Generic Name
Nucleophosmin (NPM1) antigen IVD, antibody FDA UDI
Device Name
FLEX Monoclonal Mouse Anti-Human Nucleophosmin Clone 376 Ready-to-Use (Dako Omnis) FDA UDI
Model / Reference
GA652 FDA UDI
Description
FLEX Monoclonal Mouse Anti-Human Nucleophosmin Clone 376 Ready-to-Use (Dako Omnis) FDA UDI

Identifiers

Primary DI / UDI-DI
05700572034315 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

Dimensions & Sizes

Size
Total Volume — 12 Milliliter FDA UDI

Category: Nucleophosmin (NPM1) antigen IVD, antibody

FLEX Mono Mo A-Hu Nucleophosmin Cl 376 RTU (Dako Omnis) by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Nucleophosmin (NPM1) antigen IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Agilent Technologies Singapore Pte Ltd

Sources (1)

  • FDA UDI 83e25d72-9fd4-4b97-80a6-d7f375e134ca 36 fields · synced Jun 8, 2026