Hemochron Whole Blood Coagulation System

FDA UDI

Class II (US FDA UDI)

by Accriva Diagnostics Holdings, Inc.

Identity

Trade Name: Hemochron Whole Blood Coagulation System FDA UDI
Generic Name: Activated clotting time (ACT) IVD, reagent FDA UDI
Device Name: Celite ACT Tubes - 95 tubes/box FDA UDI
Model / Reference: HRFTCA510 FDA UDI
Description: Celite ACT Tubes - 95 tubes/box FDA UDI

Identifiers

Catalog Number: HRFTCA510 FDA UDI
Primary DI / UDI-DI: 10711234101384 FDA UDI
FDA Product Code: JBP FDA UDI
GMDN Term: Activated clotting time (ACT) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Activated clotting time (ACT) IVD, reagent

Hemochron Whole Blood Coagulation System by Accriva Diagnostics Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Activated clotting time (ACT) IVD, reagent.

C-ACT Tubes — Helena Laboratories, Corp. · Class II
G-ACT Tubes — Helena Laboratories, Corp. · Class II
TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION · Class II
Actalyke MAX-ACT Tubes — Helena Laboratories, Corp. · Class II
K-ACT Tubes — Helena Laboratories, Corp. · Class II
Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II

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: Accriva Diagnostics Holdings, Inc.

Sources (1)

FDA UDI cac8868d-ad69-4e1a-8d6a-b85dea6a7dcc 36 fields · synced May 30, 2026