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Anticlotting Reagent

FDA UDI

Class I (US FDA UDI)

by Genial Helix Ltd

Identity

Trade Name
Anticlotting Reagent FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
AntiClotting Reagent Is an additive that quickly breaks down the proteins that comprise blood clots within cytogenetic samples FDA UDI
Model / Reference
GGS - JL001 FDA UDI
Description
AntiClotting Reagent Is an additive that quickly breaks down the proteins that comprise blood clots within cytogenetic samples FDA UDI

Identifiers

Catalog Number
GGS - JL001 FDA UDI
Primary DI / UDI-DI
05060174130021 FDA UDI
FDA Product Code
KIQ FDA UDI
GMDN Term
Assay development analyte-specific reagent IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.2260 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: Assay development analyte-specific reagent IVD

Anticlotting Reagent by Genial Helix Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assay development analyte-specific reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genial Helix Ltd

Sources (1)

  • FDA UDI df677e2d-2500-4f0c-a95a-c92ffbe3a02d 34 fields · synced May 30, 2026