← Back to catalogue

HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL)

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL) FDA UDI
Generic Name
Multiple haemoglobin subtype IVD, control FDA UDI
Model / Reference
HA5083 FDA UDI

Identifiers

Primary DI / UDI-DI
05055273208832 FDA UDI
FDA Product Code
GGM FDA UDI
GMDN Term
Multiple haemoglobin subtype IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8625 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

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

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: Multiple haemoglobin subtype IVD, control

HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple haemoglobin subtype IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI c3d28169-7e46-4ca1-8a99-685d0bc852b4 32 fields · synced May 30, 2026