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Wondfo

FDA UDI

Class I (US FDA UDI)

by Wondfo Usa Co., Ltd.

Identity

Trade Name
Wondfo FDA UDI
Generic Name
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing FDA UDI
Device Name
25-Strip; LH-Ovulation Test FDA UDI
Model / Reference
W2-S25-CA FDA UDI
Description
25-Strip; LH-Ovulation Test FDA UDI

Identifiers

Primary DI / UDI-DI
00816862026696 FDA UDI
FDA Product Code
NGE FDA UDI
GMDN Term
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1485 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

Wondfo by Wondfo Usa Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wondfo Usa Co., Ltd.

Sources (1)

  • FDA UDI 19fa5662-bdf1-4ab4-89b3-2f1af8719bb6 35 fields · synced May 30, 2026