FDA.reportPublic FDA data

INSTANT-VIEW Morphine/Opiates (2000) Urine Dip-Strip Test

Primary DI
10796918000535
Brand
INSTANT-VIEW Morphine/Opiates (2000) Urine Dip-Strip Test
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-3097
Device description
INSTANT-VIEW Morphine/Opiates (2000) Urine Dip-Strip Test
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010079000INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TESTAlfa Scientific Designs, Inc.2001-05-29DOE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796918000535PrimaryGS10
00796918000538Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800053510796918000535
00796918000538007969180005387969180005380796918000538

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT)A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an immunochromatographic test (ICT) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176391167
Device count
50
Kit
true
Lot or batch
true
Expiration date on label
true

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
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
10796918002447Multi-Drug of Abuse Urine Cup Test03-46802022-11-07

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
00796918002419INSTANT-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