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David Pregnancy Test Midstream

FDA UDI

Class II (US FDA UDI)

by Equinox Biotech Co., Ltd.

Identity

Trade Name
DAVID PREGNANCY TEST MIDSTREAM FDA UDI
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Device Name
David Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. FDA UDI
Model / Reference
80012 FDA UDI
Description
David Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. FDA UDI

Identifiers

Catalog Number
RH-HCG-B FDA UDI
Primary DI / UDI-DI
06938444980012 FDA UDI
510(k) Number
K053236 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

Yes

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

David Pregnancy Test Midstream by Equinox Biotech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Equinox Biotech Co., Ltd.

Sources (1)

  • FDA UDI 62b8d7dd-6dee-48e7-b371-e7b08fff8563 38 fields · synced Jun 8, 2026