FDA.reportPublic FDA data

INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, T

Primary DI
00796918002419
Brand
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, T
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-3803QW
Device description
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR, MTD, OXY, THC w/ADU
Published
2021-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.Clinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796918002416PrimaryGS10
00796918002419Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800241610796918002416
00796918002419007969180024197969180024190796918002419

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly 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
176391167
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20796918001904INSTANT-VIEW FOB Test - complete kit, 25 test05-7601-252019-07-01
30796918001901INSTANT-VIEW FOB Test - complete kit, 50 test05-7601-502019-07-01
10796918002157INSTANT-VIEW LH Midstream Cassette Test, 6 tests02-2540-62019-06-03
10796918002096INSTANT-VIEW FOB Test05-7602-502019-05-01
10796918001907INSTANT-VIEW FOB Test05-76022017-04-10
10796918001938INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)03-47012018-08-28
10796918001945INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)03-47022018-08-28
10796918002058INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)03-4701OT2019-03-26
10796918002065INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)03-4703OT2019-03-26
10796918002072INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)03-4705OT2019-03-26
10796918000115INSTANT-VIEW LH Ovulation Predicting Cassette Test02-25422016-09-21
10796918000122INSTANT-VIEW LH Ovulation Predicting Dip-Strip Test02-25472016-09-21
10796918000306INSTANT-VIEW Amphetamine Urine Dip-Strip Test03-30172016-09-21
10796918000368INSTANT-VIEW Methamphetamine Urine Dip-Strip Test03-30372016-09-21
10796918000429INSTANT-VIEW Cocaine (Benzoylecgonine) Urine Dip-Strip Test03-30572016-09-22
10796918000535INSTANT-VIEW Morphine/Opiates (2000) Urine Dip-Strip Test03-30972016-09-22
10796918000573INSTANT-VIEW Phencyclidine (PCP) Urine Dip-Strip Test03-31172016-09-22
10796918000603INSTANT-VIEW Benzodiazepine (BZD) Urine Dip-Strip Test03-31372016-09-22
10796918000634INSTANT-VIEW Barbiturate Urine Dip-Strip Test03-31572016-09-22
10796918000665INSTANT-VIEW Methadone Urine Dip-Strip Test03-31772016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10796918002447Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.DOE2022-11-07
10796918002430Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DOE2021-09-24
10796918002423INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300ALFA SCIENTIFIC DESIGNS, INC.DOE2021-07-29
10796918002416INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, TALFA SCIENTIFIC DESIGNS, INC.DOE2021-07-12
10796918002201INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300ALFA SCIENTIFIC DESIGNS, INC.DOE2021-04-21
10796918002195INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30ALFA SCIENTIFIC DESIGNS, INC.DOE2020-09-14
10796918002188INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DOE2019-09-23
10796918002171INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DOE2019-06-12
10796918002133INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THCALFA SCIENTIFIC DESIGNS, INC.DOE2019-05-03
10796918002034INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test ALFA SCIENTIFIC DESIGNS, INC.DOE2019-05-01
10796918002089INSTANT-VIEW Multi-Drugs of Abuse Urine TestALFA SCIENTIFIC DESIGNS, INC.DOE2019-05-01
10796918002102Instant-View Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DOE2019-03-29
10796918002058INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DOE2019-03-26
10796918002065INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DOE2019-03-26
10796918002041INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200ALFA SCIENTIFIC DESIGNS, INC.DOE2019-02-06
10796918002010INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DOE2018-12-14
10796918002027INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test ALFA SCIENTIFIC DESIGNS, INC.DOE2018-12-14
10796918001938INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)ALFA SCIENTIFIC DESIGNS, INC.DOE2018-08-28
10796918001945INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)ALFA SCIENTIFIC DESIGNS, INC.DOE2018-08-28
10796918001952INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)ALFA SCIENTIFIC DESIGNS, INC.DOE2018-08-28
00895330002844Healgen (Private Label) FLATCUP-6125A3CONFIRM BIOSCIENCES, INC.DOE2017-01-19
10796918001891Instant-View Multi-Drugs of Abuse Dip Test AMP, COC, MET, MOR, THC, XTCALFA SCIENTIFIC DESIGNS, INC.DOE2017-01-03
10796918001884INSTANT-VIEW Multi-Drugs of Abuse Urine Test (AMP, BZD, COC, MET, MOR300, THC)ALFA SCIENTIFIC DESIGNS, INC.DOE2016-11-18
10796918001853Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DOE2016-10-05
10796918001860Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI OXY PCP THCALFA SCIENTIFIC DESIGNS, INC.DOE2016-10-05
10796918001877Multi-Drug of Abuse Urine Cup Test AMP BAR BZD COC MET MOR/OPI MTD PCP PPX THCALFA SCIENTIFIC DESIGNS, INC.DOE2016-10-05
10796918001020INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, PCP, THCALFA SCIENTIFIC DESIGNS, INC.DOE2016-09-23
10796918001037INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THCALFA SCIENTIFIC DESIGNS, INC.DOE2016-09-23
10796918001044INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, MOR2000, PCP, THCALFA SCIENTIFIC DESIGNS, INC.DOE2016-09-23
10796918001051INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, MOR300, PCP, THCALFA SCIENTIFIC DESIGNS, INC.DOE2016-09-23