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ADVIA Chemistry Enzymatic Hemoglobin A1c

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Chemistry Enzymatic Hemoglobin A1c FDA UDI
Generic Name
Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry FDA UDI
Device Name
ADVIA A1c_E Reagent (Large Kit), 1200 tests FDA UDI
Model / Reference
10720858 FDA UDI
Description
ADVIA A1c_E Reagent (Large Kit), 1200 tests FDA UDI

Identifiers

Catalog Number
10720858 FDA UDI
Primary DI / UDI-DI
00630414002866 FDA UDI
FDA Product Code
LCP FDA UDI
PDJ FDA UDI
GMDN Term
Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7470 FDA UDI
862.1373 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

Category: Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry

ADVIA Chemistry Enzymatic Hemoglobin A1c by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI e5c84b1e-fbb7-48bc-89f1-8dde6618601a 36 fields · synced Jun 8, 2026