FIRSTVIEW Fentanyl Urine Test Cassette FYL-1012

GUDID 06974246461496

Safecare Biotech (Hangzhou) Co., Ltd.

Fentanyl IVD, kit, rapid ICT, clinical
Primary Device ID06974246461496
NIH Device Record Keybe897601-acc1-40b6-9a46-a2616cca53fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIRSTVIEW Fentanyl Urine Test Cassette
Version Model Number5 tests
Catalog NumberFYL-1012
Company DUNS544349634
Company NameSafecare Biotech (Hangzhou) Co., Ltd.
Device Count1
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
GS106974246461496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGLTest, Opiates, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-28

Devices Manufactured by Safecare Biotech (Hangzhou) Co., Ltd.

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06974246461656 - Welcheck Vaginal PH Rapid Test Cassette2024-10-24
06974246461663 - Welcheck URINARY TRACT INFECTION TEST2024-10-24
06974246461670 - Welcheck URINARY TRACT INFECTION TEST2024-10-24
06974246461588 - T Testahead Multi-Drug Urine Test Dip Card2024-09-23

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