HEPRO.US - Gel & Clot Activator Tube

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name: HEPRO.US - Gel & Clot Activator Tube FDA UDI
Generic Name: Culture tube FDA UDI
Device Name: Gel & Clot Activator Tube, with serum for determinations in chemistry and serology. Pack of 100 FDA UDI
Model / Reference: Pack Gel Clot Test Tubes FDA UDI
Description: Gel & Clot Activator Tube, with serum for determinations in chemistry and serology. Pack of 100 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850578007631 FDA UDI
FDA Product Code: JKA FDA UDI
GMDN Term: Culture tube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Culture tube

HEPRO.US - Gel & Clot Activator Tube by Hepro.us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Hepro.us Inc.

Sources (1)

FDA UDI afb15344-46df-4ea1-99d8-363b54fbf9e9 33 fields · synced May 30, 2026