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directCHECK Whole Blood Controls

FDA UDI

Class II (US FDA UDI)

by Accriva Diagnostics Holdings, Inc.

Identity

Trade Name
directCHECK Whole Blood Controls FDA UDI
Generic Name
Coagulation analyser IVD, point-of-care, line-powered FDA UDI
Device Name
Protective Sleeves FDA UDI
Model / Reference
DCJ-005 FDA UDI
Description
Protective Sleeves FDA UDI

Identifiers

Catalog Number
DCJ-005 FDA UDI
Primary DI / UDI-DI
10711234540046 FDA UDI
510(k) Number
K120977 FDA UDI
FDA Product Code
GGN FDA UDI
GMDN Term
Coagulation analyser IVD, point-of-care, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5425 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coagulation analyser IVD, laboratoryCoagulation analyser IVD, point-of-care, line-powered

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

Similar devices

Also classified as Coagulation analyser IVD, point-of-care, line-powered.

Cleared under the same submission

K120977 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accriva Diagnostics Holdings, Inc.

Sources (1)

  • FDA UDI d514429f-6729-41ae-a744-b4798cab6871 36 fields · synced May 30, 2026