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Anti-HbF R-PE

FDA UDI

Class I (US FDA UDI)

by IQ Products B.V.

Identity

Trade Name
Anti-HbF R-PE FDA UDI
Generic Name
Haemoglobin F (HbF) IVD, reagent FDA UDI
Device Name
The R-PE conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form. FDA UDI
Model / Reference
IQP-567R FDA UDI
Description
The R-PE conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form. FDA UDI

Identifiers

Catalog Number
IQP-567R FDA UDI
Primary DI / UDI-DI
08719327450963 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Haemoglobin F (HbF) 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemoglobin F (HbF) IVD, reagent

Anti-HbF R-PE by IQ Products B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemoglobin F (HbF) IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IQ Products B.V.

Sources (1)

  • FDA UDI 4e2b36c5-bede-4f41-be52-a04e8079fba7 36 fields · synced May 31, 2026