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Azur Pure Helical

FDA UDI

Class II (US FDA UDI)

by Microvention Inc.

Identity

Trade Name
Azur Pure Helical FDA UDI
Generic Name
Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator FDA UDI
Device Name
Azur FDA UDI
Model / Reference
45-080606 FDA UDI
Description
Azur FDA UDI

Identifiers

Catalog Number
45-080606 FDA UDI
Primary DI / UDI-DI
00810170018206 FDA UDI
FDA Product Code
KRD FDA UDI
GMDN Term
Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator

Azur Pure Helical by Microvention Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microvention Inc.

Sources (1)

  • FDA UDI 840a9eb8-8f2f-446a-b387-f248bdae34ba 36 fields · synced May 31, 2026