FOB Rapid Test Cassette TFO-602

GUDID 06970277512473

FOB Rapid Test Cassette Box of 25 kits.

Hangzhou AllTest Biotech Co., Ltd.

Faecal occult blood IVD, reagent
Primary Device ID06970277512473
NIH Device Record Key92d1d6a8-a54d-4b1a-b8f6-3a05a3ab1b56
Commercial Distribution StatusIn Commercial Distribution
Brand NameFOB Rapid Test Cassette
Version Model NumberTFO-602
Catalog NumberTFO-602
Company DUNS543254717
Company NameHangzhou AllTest Biotech Co., Ltd.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970277512411 [Unit of Use]
GS106970277512473 [Primary]

FDA Product Code

KHEReagent, Occult Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-08
Device Publish Date2018-09-06

Devices Manufactured by Hangzhou AllTest Biotech Co., Ltd.

06936983168649 - DrugTect Multi-Drug 14 Drugs Rapid Urine Test Cup2025-02-21 FDA Clia Waived, 25T, MOP300/MDMA500/OXY100/PCP25/COC150/MTD300/BAR300/BZO300/AMP500/MET500/TCA1000/THC50/BUP10/FYL1 + (OXI/SG
16936983165416 - Multi-Drug 13 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/FYL1
16936983165447 - Alltest Multi-Drug 12 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1
16936983165454 - Alltest Multi-Drug 14 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
16936983165461 - Multi-Drug 12 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1
16936983165478 - Multi-Drug 14 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
16936983165522 - Multi-Drug 14 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1)+(OXI/CRE/pH)
06936983166256 - iScreen Urine Test DX Drug Screen Tox Cup2024-09-16 25T, FDA, CLIA WAIVED (AMP500/BAR300/BUP10/BZO300/COC150/FTY1/MDMA500/MET500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50)+(OXI/CRE/
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.