FDA.reportPublic FDA data

AllTest Fentanyl Rapid Test

Primary DI
06936983138857
Brand
AllTest Fentanyl Rapid Test
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
DFY-A102
Device description
1T, EN, FDA, RX,1ng, White pouch
Published
2026-04-16
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
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936983138642PrimaryGS10
06936983138857Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936983138642069369831386426936983138642
06936983138857069369831388576936983138857

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
543254717
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936983120081One Step FSH Rapid Test Midstream (Urine)1FFS-103H2026-09-22
06936983113793Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)1FHC-A2022026-04-22
06936983113809Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)1FHC-A2022026-04-22
06936983114721Alltest BZO300 Home Rapid Test Panel (Urine)1DBZ-A114H (300ng)2026-04-22
06936983114738Alltest BAR300 Home Rapid Test Panel (Urine)1DBA-A114H (300ng)2026-04-22
06936983114745Alltest AMP500 Home Rapid Test Panel (Urine)1DAM-A114H (500ng)2026-04-22
06936983114752Alltest MOP2000 Home Rapid Test Panel(Urine)1DOP-A114H (2000ng)2026-04-22
06936983114769Alltest MOP300 Home Rapid Test Panel (Urine)1DMO-A114H (300ng)2026-04-22
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)1DMD-A114 (500ng)2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)1DME-A114 (500ng)2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)1DMO-A114 (300ng)2026-04-21
06936983113960Alltest MTD300 Rapid Test Panel (Urine)1DMT-A114 (300ng)2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)1DOP-A114 (2000ng)2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)1DOX-A114 (100ng)2026-04-21
06936983113991Alltest PCP25 Rapid Test Panel (Urine)1DPC-A114 (25ng)2026-04-21
06936983114004Alltest TCA1000 Rapid Test Panel (Urine)1DTC-A114 (1000ng)2026-04-21
06936983114011Alltest THC50 Rapid Test Panel (Urine)1DTH-A114 (50ng)2026-04-21
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)1DAM-A101 (500ng)2026-04-21
06936983114035Alltest BAR300 Rapid Test Dipstick (Urine)1DBA-A101 (300ng)2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)1DBU-A101 (10ng)2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29