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VARIANT II B-thalassemia

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
VARIANT II B-thalassemia FDA UDI
Generic Name
Haemoglobin A2 (HbA2) IVD, calibrator FDA UDI
Device Name
VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set FDA UDI
Model / Reference
270-0083 FDA UDI
Description
VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set FDA UDI

Identifiers

Catalog Number
2700083 FDA UDI
Primary DI / UDI-DI
00847817009204 FDA UDI
510(k) Number
K991127 FDA UDI
FDA Product Code
JPD FDA UDI
GMDN Term
Haemoglobin A2 (HbA2) IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Yes

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: Haemoglobin A2 (HbA2) IVD, calibratorHaemoglobin F (HbF) IVD, calibratorInherited haemoglobinopathy IVD, calibrator

VARIANT II B-thalassemia 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, calibrator.

Cleared under the same submission

K991127 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 a877201a-8e0c-46dd-9ecb-1bb26c68ef6b 37 fields · synced May 30, 2026