← Back to catalogue

WELLlife™

FDA UDI

Class II (US FDA UDI)

by Wondfo Usa Co., Ltd.

Identity

Trade Name
WELLlife™ FDA UDI
Generic Name
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
Device Name
1 iFOB Fecal Occult Blood Test OTC; 1 Cassettes + 1 Collection Tube + 1 Collection Paper FDA UDI
Model / Reference
WFOB-OTC-1BX FDA UDI
Description
1 iFOB Fecal Occult Blood Test OTC; 1 Cassettes + 1 Collection Tube + 1 Collection Paper FDA UDI

Identifiers

Primary DI / UDI-DI
00816862025972 FDA UDI
510(k) Number
K162333 FDA UDI
FDA Product Code
KHE FDA UDI
GMDN Term
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.6550 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

No

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

Category: Faecal occult blood IVD, kit, rapid ICT, clinical

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

Similar devices

Also classified as Faecal occult blood IVD, kit, rapid ICT, clinical.

Cleared under the same submission

K162333 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Wondfo Usa Co., Ltd.

Sources (1)

  • FDA UDI b8385108-ae25-453b-8e3a-7a5febc2ed75 36 fields · synced Jun 8, 2026