WELLlife™

FDA UDI

Class N (US FDA UDI)

by Wondfo Usa Co., Ltd.

Identity

Trade Name: WELLlife™ FDA UDI
Generic Name: SARS-CoV-2 antigen IVD, control FDA UDI
Device Name: WELLlife™ COVID-19/Influenza A&B Test Control Kit, 5 Positive Control Swabs and 5 Negative Control Swabs per Kitbox FDA UDI
Model / Reference: WV01P0003 FDA UDI
Description: WELLlife™ COVID-19/Influenza A&B Test Control Kit, 5 Positive Control Swabs and 5 Negative Control Swabs per Kitbox FDA UDI

Identifiers

Primary DI / UDI-DI: 00816862024609 FDA UDI
FDA Product Code: QKP FDA UDI
OHQ FDA UDI
GMDN Term: SARS-CoV-2 antigen IVD, control FDA UDI

Classification

Device Class: N FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: SARS-CoV-2 antigen IVD, control

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

Similar devices

Also classified as SARS-CoV-2 antigen IVD, control.

SARS-CoV-2 Control Slides — BIO SB, INC. · Class I
BinaxNOW COVID-19 Ag Positive Control Swab Pack — Alere Scarborough, Inc. · N
Helix Elite™ Molecular Standards: Inactivated Standard — MICROBIOLOGICS, INC. · Class I
Lumipulse SARS-CoV-2 Ag Controls — FUJIREBIO INC.
VITROS — Ortho-Clinical Diagnostics · N
Audit MicroControls Control FD COVID-19 Antigen – Nucleocapsid — Aalto Scientific, Ltd.

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 N	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Wondfo Usa Co., Ltd.

Sources (1)

FDA UDI 560e6bea-ec3a-450e-a391-1a8f69059661 35 fields · synced Jun 8, 2026