Sunmark Pregnancy Test One Step

FDA UDI

Class II (US FDA UDI)

by Mckesson Corp.

Identity

Trade Name: Sunmark Pregnancy Test One Step FDA UDI
Generic Name: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Device Name: FPPL Sunmark DPS +/- FDA UDI
Model / Reference: FPPL FDA UDI
Description: FPPL Sunmark DPS +/- FDA UDI

Identifiers

Primary DI / UDI-DI: 00010939163332 FDA UDI
510(k) Number: K042280 FDA UDI
FDA Product Code: LCX FDA UDI
GMDN Term: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1155 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

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

Sunmark Pregnancy Test One Step by Mckesson Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K042280 also covers:

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: Mckesson Corp.

Sources (1)

FDA UDI cfd5b15a-cdff-4234-9bd1-fef0bdedc632 37 fields · synced May 29, 2026