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D-10

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
D-10 FDA UDI
Generic Name
Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
Device Name
D-10 Analytical Cartridge Hemoglobin A1c Program or Hemoglobin A2/F/A1c Program FDA UDI
Model / Reference
220-0212 FDA UDI
Description
D-10 Analytical Cartridge Hemoglobin A1c Program or Hemoglobin A2/F/A1c Program FDA UDI

Identifiers

Catalog Number
2200212 FDA UDI
Primary DI / UDI-DI
00847817003462 FDA UDI
510(k) Number
K041444 FDA UDI
FDA Product Code
JPD FDA UDI
LCP FDA UDI
GMDN Term
Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7400 FDA UDI
864.7470 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

Yes

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

Category: Glycated haemoglobin (HbA1c) IVD, reagentHaemoglobin F (HbF) IVD, reagentHaemoglobin A2 (HbA2) IVD, reagent

D-10 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemoglobin A2 (HbA2) IVD, reagent.

Cleared under the same submission

K041444 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 671e5841-5ee3-40b2-ad72-c49ebafaf55a 37 fields · synced Jun 1, 2026