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FLEX Poly Rb A-Hu IgG RTU

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name
FLEX Poly Rb A-Hu IgG RTU FDA UDI
Generic Name
Total immunoglobulin G (IgG total) IVD, antibody FDA UDI
Device Name
FLEX Polyclonal Rabbit Anti-Human IgG Ready-to-Use (Dako Autostainer/ Autostainer Plus) FDA UDI
Model / Reference
IS512 FDA UDI
Description
FLEX Polyclonal Rabbit Anti-Human IgG Ready-to-Use (Dako Autostainer/ Autostainer Plus) FDA UDI

Identifiers

Primary DI / UDI-DI
05700572029687 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Total immunoglobulin G (IgG total) 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: Total immunoglobulin G (IgG total) IVD, antibody

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

Similar devices

Also classified as Total immunoglobulin G (IgG total) IVD, antibody.

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 8b84b635-e474-4c3e-986a-63a8fa9ce94c 36 fields · synced Jun 6, 2026