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Solid Tumor Growth Supplement

FDA UDI

Class I (US FDA UDI)

by Genial Helix Ltd

Identity

Trade Name
Solid Tumor Growth Supplement FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
Solid Tumour Growth Supplement is a media additive that greatly improves cell growth and morphology in primary solid tumour cultures by exposing these cells to growth factors and cofactors that are known growth promoters. FDA UDI
Model / Reference
GGS - JL010 FDA UDI
Description
Solid Tumour Growth Supplement is a media additive that greatly improves cell growth and morphology in primary solid tumour cultures by exposing these cells to growth factors and cofactors that are known growth promoters. FDA UDI

Identifiers

Catalog Number
GGS - JL010 FDA UDI
Primary DI / UDI-DI
05060174130182 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

Solid Tumor Growth Supplement 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 bae6c49b-7e3f-497c-8e8c-c5c391c30ad7 34 fields · synced May 30, 2026