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Sunmark

FDA UDI

Class II (US FDA UDI)

by Mckesson Corp.

Identity

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

Identifiers

Primary DI / UDI-DI
00010939953889 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

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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Sunmark 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

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Manufacturer

Manufacturer
Mckesson Corp.

Sources (1)

  • FDA UDI 2f9a08f1-7610-407f-8198-a6d51a048157 37 fields · synced May 30, 2026