D-10 Dual

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name: D-10 Dual FDA UDI
Generic Name: Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
Device Name: D-10 Dual Program HbA1c Calibrator/Diluent Set FDA UDI
Model / Reference: 220-0128 FDA UDI
Description: D-10 Dual Program HbA1c Calibrator/Diluent Set FDA UDI

Identifiers

Catalog Number: 2200128 FDA UDI
Primary DI / UDI-DI: 00847817003394 FDA UDI
510(k) Number: K041444 FDA UDI
FDA Product Code: JIT FDA UDI
LCP FDA UDI
GMDN Term: Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
864.7470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glycated haemoglobin (HbA1c) IVD, calibrator

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

Similar devices

Also classified as Glycated haemoglobin (HbA1c) IVD, calibrator.

Diazyme — Diazyme Laboratories, Inc.
Alfa Wassermann — Alfa Wassermann, Inc. · Class II
Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
HbA1C CAL — Randox Laboratories, Ltd. · Class II
Chemistry HbA1c Calibrator Kit — Medica Corp. · Class II
Trinity Biotech — Primus Corp. · Class II
HbA1c II CALIBRATOR SET (HbA1c II CAL) — Randox Laboratories, Ltd. · Class II
Direct Glycohemoglobin (HbA1c) Calibrator Set — STANBIO LABORATORY, L.P. · Class II

Cleared under the same submission

K041444 also covers:

D-10 — Bio-Rad Laboratories
D-10 — Bio-Rad Laboratories
D-10 — Bio-Rad Laboratories
D-10 — Bio-Rad Laboratories
D-10 Dual — Bio-Rad Laboratories
D-10 Dual — Bio-Rad Laboratories
D-10 Dual — Bio-Rad Laboratories
D-10 Dual — Bio-Rad Laboratories
Whole Blood Primer — Bio-Rad Laboratories

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bio-Rad Laboratories

Sources (1)

FDA UDI 048fc194-72ca-4e03-9ff7-57d0d49a097e 37 fields · synced Jun 8, 2026