Device
2 iFOB Fecal Occult Blood Test OTC; 2 Cassettes + 2 Collection Tubes + 2 Collection Papers
Manufacturer
WONDFO USA CO., LTD.
WONDFO USA CO., LTD.
Model: WFOB-OTC-2BX
DI: 00816862028324
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-15
Current Version: 2026-05-25
Description
2 iFOB Fecal Occult Blood Test OTC; 2 Cassettes + 2 Collection Tubes + 2 Collection Papers
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
437bbd56-4f5c-4d60-9669-d96b14574438
Distribution Status:
In Commercial Distribution
DUNS Number:
849098897
Device Count:
2
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00816862027549
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00816862028324
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 54532
Name: Faecal occult blood IVD, kit, rapid ICT, clinical
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
FDA Product Codes
KHE
Reagent, Occult Blood
Premarket Submissions
Submission Number:
K162333
Supplement Number:
000