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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
Haemoglobin A2 (HbA2) IVD, reagent FDA UDI
Device Name
D-10 Wash/Diluent Solution FDA UDI
Model / Reference
220-0112 FDA UDI
Description
D-10 Wash/Diluent Solution FDA UDI

Identifiers

Catalog Number
2200112 FDA UDI
Primary DI / UDI-DI
00847817003301 FDA UDI
510(k) Number
K031043 FDA UDI
K041444 FDA UDI
FDA Product Code
LCP FDA UDI
JPD FDA UDI
GMDN Term
Haemoglobin A2 (HbA2) IVD, reagent FDA UDI

Classification

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

Yes

FDA UDI

Category: Glycated haemoglobin (HbA1c) 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

K031043 also covers:

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 3bb6b497-9a25-4b67-bbe2-803f464a61f2 37 fields · synced Jun 6, 2026