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Quik Column Equipment Kit

FDA UDI

Class I (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
Quik Column Equipment Kit FDA UDI
Generic Name
Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI
Model / Reference
5336 FDA UDI

Identifiers

Primary DI / UDI-DI
M52553360 FDA UDI
FDA Product Code
LXG FDA UDI
GMDN Term
Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Inherited haemoglobinopathy IVD, kit, liquid chromatography

Quik Column Equipment Kit by Helena Laboratories, Corp. — Class I — 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
Helena Laboratories, Corp.

Sources (1)

  • FDA UDI 9b1eaab9-22a3-41be-904b-3457e9688239 33 fields · synced Jun 9, 2026