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Tina-quant Hemoglobin A1cDx Gen.3

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Tina-quant Hemoglobin A1cDx Gen.3 FDA UDI
Generic Name
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
08056668190 FDA UDI

Identifiers

Catalog Number
08056668190 FDA UDI
Primary DI / UDI-DI
07613336120927 FDA UDI
FDA Product Code
PDJ FDA UDI
LCP FDA UDI
GMDN Term
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1373 FDA UDI
864.7470 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Category: Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Tina-quant Hemoglobin A1cDx Gen.3 by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI 28ade75e-7c5f-42d0-882d-1f81d2e57a1b 34 fields · synced May 30, 2026