anti-HbS PURE

FDA UDI

Class I (US FDA UDI)

by IQ Products B.V.

Identity

Trade Name: anti-HbS PURE FDA UDI
Generic Name: Haemoglobin S (HbS) IVD, reagent FDA UDI
Device Name: The purified monoclonal antibody anti-Hemoglobin S (HbS) recognizes the B-chain of the human hemoglobin. FDA UDI
Model / Reference: IQP-574P FDA UDI
Description: The purified monoclonal antibody anti-Hemoglobin S (HbS) recognizes the B-chain of the human hemoglobin. FDA UDI

Identifiers

Catalog Number: IQP-574P FDA UDI
Primary DI / UDI-DI: 08719327450987 FDA UDI
FDA Product Code: MVU FDA UDI
GMDN Term: Haemoglobin S (HbS) IVD, reagent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4020 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Haemoglobin S (HbS) IVD, reagent

anti-HbS PURE by IQ Products B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: IQ Products B.V.

Sources (1)

FDA UDI ac35d1c9-7c04-40a1-b436-5faf9d30e35f 36 fields · synced May 30, 2026