Hepatitis C Check

FDA UDI

Class II (US FDA UDI)

by Home Access Health Corp.

Identity

Trade Name: Hepatitis C Check FDA UDI
Generic Name: Capillary blood collection set, home-use FDA UDI
Device Name: The Home Access Health Corporation Hepatitis C Check Test System is intended for use by persons to determine if antibodies to HCV (Hepatitis C) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. FDA UDI
Model / Reference: 27 FDA UDI
Description: The Home Access Health Corporation Hepatitis C Check Test System is intended for use by persons to determine if antibodies to HCV (Hepatitis C) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. FDA UDI

Identifiers

Primary DI / UDI-DI: M769HCV271 FDA UDI
PMA Number: P980046 FDA UDI
FDA Product Code: MZO FDA UDI
GMDN Term: Capillary blood collection set, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3169 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

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Capillary blood collection set, home-use

Hepatitis C Check by Home Access Health Corp. — 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: Home Access Health Corp.

Sources (1)

FDA UDI 1334b700-2c3a-4a02-9ec7-ffa2c152ce44 35 fields · synced May 30, 2026