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Poly Rb a Hu Alpha-1-Antitrypsin

FDA UDI

Class II (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name
Poly Rb a Hu Alpha-1-Antitrypsin FDA UDI
Generic Name
Alpha-1-antitrypsin (protease inhibitor) IVD, antibody FDA UDI
Device Name
Polyclonal Rabbit Anti-Human Alpha-1-Antitrypsin FDA UDI
Model / Reference
A0012 FDA UDI
Description
Polyclonal Rabbit Anti-Human Alpha-1-Antitrypsin FDA UDI

Identifiers

Primary DI / UDI-DI
05700572000273 FDA UDI
FDA Product Code
DEW FDA UDI
GMDN Term
Alpha-1-antitrypsin (protease inhibitor) IVD, antibody FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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

No

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 — 2 Milliliter FDA UDI

Category: Alpha-1-antitrypsin (protease inhibitor) IVD, antibody

Poly Rb a Hu Alpha-1-Antitrypsin by Agilent Technologies Singapore Pte Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alpha-1-antitrypsin (protease inhibitor) 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 12a0a9e4-9a10-4c12-9e51-7416f9d39b4f 36 fields · synced May 30, 2026