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FLEX Poly Rb A-Hu IgA RTU (Dako Omnis)

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name
FLEX Poly Rb A-Hu IgA RTU (Dako Omnis) FDA UDI
Generic Name
Immunoglobulin A antibody (anti-IgA) IVD, reagent FDA UDI
Device Name
FLEX Polyclonal Rabbit Anti-Human IgA Ready-to-Use (Dako Omnis) FDA UDI
Model / Reference
GA510 FDA UDI
Description
FLEX Polyclonal Rabbit Anti-Human IgA Ready-to-Use (Dako Omnis) FDA UDI

Identifiers

Primary DI / UDI-DI
05700572034094 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Immunoglobulin A antibody (anti-IgA) IVD, reagent 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: Immunoglobulin A antibody (anti-IgA) IVD, reagent

FLEX Poly Rb A-Hu IgA RTU (Dako Omnis) by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Immunoglobulin A antibody (anti-IgA) IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Agilent Technologies Singapore Pte Ltd

Sources (1)

  • FDA UDI 5fe6c2fb-0c19-4c42-93af-b024a96002e1 36 fields · synced May 30, 2026