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VARIANT nbs Newborn Screening

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
VARIANT nbs Newborn Screening FDA UDI
Generic Name
Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI
Device Name
VARIANT nbs Newborn Screening System FDA UDI
Model / Reference
250-3010 FDA UDI
Description
VARIANT nbs Newborn Screening System FDA UDI

Identifiers

Catalog Number
2503010 FDA UDI
Primary DI / UDI-DI
00847817000560 FDA UDI
FDA Product Code
GKA FDA UDI
GMDN Term
Inherited haemoglobinopathy IVD, kit, liquid chromatography 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Inherited haemoglobinopathy IVD, kit, liquid chromatography

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

Similar devices

Also classified as Inherited haemoglobinopathy IVD, kit, liquid chromatography.

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 ad8cc83e-b577-448b-a15e-fdc58d09c539 36 fields · synced May 31, 2026