FDA.reportPublic FDA data

FIRSTVIEW Fentanyl Urine Test Cassette

Primary DI
06974246461496
Brand
FIRSTVIEW Fentanyl Urine Test Cassette
Company
Safecare Biotech (Hangzhou) Co., Ltd.
Model
5 tests
Catalog number
FYL-1012
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGLTest, Opiates, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240654000SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.2024-04-10NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974246461496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974246461496069742464614966974246461496

GMDN Terms#

Term, Definition table
TermDefinition
Fentanyl IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fentanyl in a clinical specimen 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544349634
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974246462905Safecare Vaginal PH Rapid Test Cassette3 TestsPH-60122026-03-18
06974246462936Exploro Urinary Tract Infection (UTI) Test15 testsUTI-12026-03-09
06974246462943Exploro Urinary Tract Infection (UTI) Test10 testsUTI-12026-03-09
06974246462950Exploro Urinary Tract Infection (UTI) Test7 testsUTI-12026-03-09
06974246462967Exploro Urinary Tract Infection (UTI) Test5 testsUTI-12026-03-09
06974246462974Exploro Urinary Tract Infection (UTI) Test4 testsUTI-12026-03-09
06974246462981Exploro Urinary Tract Infection (UTI) Test3 testsUTI-12026-03-09
06974246462851Analysis Oasis Marijuana (THC) Urine Strip Test25 TestsTHC-10112026-02-04
06974246462868Analysis Oasis Marijuana (THC) Urine Strip Test15 TestsTHC-10112026-02-04
06974246462875Analysis Oasis Marijuana (THC) Urine Strip Test10 TestsTHC-10112026-02-04
06974246462882Analysis Oasis Marijuana (THC) Urine Strip Test5 TestsTHC-10112026-02-04
06974246462899Analysis Oasis Marijuana (THC) Urine Strip Test3 TestsTHC-10112026-02-04
06974246462813Deteta THC Urine Test15 TestsD.1012025-11-05
06974246462820Deteta THC Urine Test10 TestsD.1012025-11-05
06974246462837Deteta THC Urine Test5 TestsD.1012025-11-05
06974246462424Exploro Highly Sensitive Urine Drug Test (14-Panel)10 testsMULTID14-12025-07-30
06974246462431Exploro Highly Sensitive Urine Drug Test (14-Panel)5 testsMULTID14-12025-07-30
06974246462448Exploro Highly Sensitive Urine Drug Test (14-Panel)4 testsMULTID14-12025-07-30
06974246462455Exploro Highly Sensitive Urine Drug Test (14-Panel)3 testsMULTID14-12025-07-30
06974246462462Exploro Highly Sensitive Urine Drug Test (14-Panel)2 testsMULTID14-12025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
10722066005511Rapid ResponseBTNX IncNGL2026-10-09
10722066018979Rapid ResponseBTNX IncNGL2026-10-08
10722066019013Rapid ResponseBTNX IncNGL2026-10-08
10722066019020Rapid ResponseBTNX IncNGL2026-10-08
10722066019037Rapid ResponseBTNX IncNGL2026-10-08
10722066019044Rapid ResponseBTNX IncNGL2026-10-08
10722066018955Rapid ResponseBTNX IncNGL2026-10-06
10722066018696Rapid ResponseBTNX IncNGL2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-08-14
06936983113953Alltest MOP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114103Alltest MOP300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114127Alltest MOP2000 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114134Alltest OXY100 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114202Alltest BUP10 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114226Alltest OXY100 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114240Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114301Alltest MOP2000 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114325Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114400Alltest MOP2000 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114417Alltest OXY100 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114462Alltest BUP10 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21