VARIANT nbs

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name: VARIANT nbs FDA UDI
Generic Name: Inherited haemoglobinopathy IVD, reagent FDA UDI
Device Name: VARIANT nbs Sickle Cell Program Wash Solution FDA UDI
Model / Reference: 250-3008 FDA UDI
Description: VARIANT nbs Sickle Cell Program Wash Solution FDA UDI

Identifiers

Catalog Number: 2503008 FDA UDI
Primary DI / UDI-DI: 00847817008344 FDA UDI
510(k) Number: K051072 FDA UDI
FDA Product Code: GKA FDA UDI
GMDN Term: Inherited haemoglobinopathy IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7415 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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: Inherited haemoglobinopathy IVD, reagent

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

Similar devices

Also classified as Inherited haemoglobinopathy IVD, reagent.

Sickle-Thal Quik Column Kit — Helena Laboratories, Corp. · Class II
SPIFE Nexus Alkaline Hemoglobin Gel Kit — Helena Laboratories, Corp. · Class II
SPIFE Acid Hemoglobin Kit — Helena Laboratories, Corp. · Class II
QuickGel Acid Hemoglobin 10/20 Gel Kit — Helena Laboratories, Corp. · Class II
SPIFE 4000 Alkaline Hemoglobin Gel Kit — Helena Laboratories, Corp. · Class II
Beta-Thal HbA2 Quik Column Kit — Helena Laboratories, Corp. · Class II
SPIFE Acid Hemoglobin Kit — Helena Laboratories, Corp. · Class II
QuickGel Applicator Blade and Shallow Well Cups — Helena Laboratories, Corp. · Class II

Cleared under the same submission

K051072 also covers:

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 8334e333-df5b-42b4-ac43-14f875eb835b 37 fields · synced May 30, 2026