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David

FDA UDI

Class I (US FDA UDI)

by Equinox Biotech Co., Ltd.

Identity

Trade Name
DAVID FDA UDI
Generic Name
Natural conception assistance kit FDA UDI
Device Name
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use. FDA UDI
Model / Reference
RH-LH-B FDA UDI
Description
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use. FDA UDI

Identifiers

Catalog Number
RH-LH-B FDA UDI
Primary DI / UDI-DI
06938444980036 FDA UDI
FDA Product Code
NGE FDA UDI
GMDN Term
Natural conception assistance kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1485 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

David by Equinox Biotech Co., Ltd. — Class I — 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 643edb59-547a-41d6-a865-a5b5f2cd453b 37 fields · synced May 30, 2026