FDA.reportPublic FDA data

INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test

Primary DI
10796918000207
Brand
INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-2932
Device description
INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test
Published
2016-09-21
Public version status
Update
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
JXNEnzyme Immunoassay, Propoxyphene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796918000207PrimaryGS10
00796918000200Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800020710796918000207
00796918000200007969180002007969180002000796918000200

GMDN Terms#

Term, Definition table
TermDefinition
Propoxyphene IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of propoxyphene in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176391167
Device count
25
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
00796918002440Multi-Drug of Abuse Urine Cup Test03-46802022-11-07
00796918002433Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THC03-44392021-09-24
00796918002426INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR30003-39482021-07-29
00796918002419INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, T03-3803QW2021-07-12
00796918002204INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR30003-39422021-04-21
00796918002198INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR3003-39452020-09-14
20796918001904INSTANT-VIEW FOB Test - complete kit, 25 test05-7601-252019-07-01
30796918001901INSTANT-VIEW FOB Test - complete kit, 50 test05-7601-502019-07-01
10796918002096INSTANT-VIEW FOB Test05-7602-502019-05-01
10796918001778INSTANT-VIEW FOB Test05-76022016-09-23
10796918001785INSTANT-VIEW FOB Test05-7602-22016-09-23
10796918001907INSTANT-VIEW FOB Test05-76022017-04-10
10796918001914Instant-view plus Immunochemical Fecal Occult Blood Test05-76322018-08-28
10796918001921Instant-view plus Immunochemical Fecal Occult Blood Test05-7632OT2018-08-28
10796918002188INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THC03-35512019-09-23
10796918002171INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET, MOR300, THC03-34622019-06-12
10796918002157INSTANT-VIEW LH Midstream Cassette Test, 6 tests02-2540-62019-06-03
10796918002164INSTANT-VIEW FSH Midstream Cassette Test02-25602019-06-03
10796918002140 Instant-View HCG Midstream Cassette, 2t02-2480-22019-05-30
10796918002119INSTANT-VIEW Marijuana (THC) Urine Dip Cassette Test03-3072OT-52019-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810124273672SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.JXN2024-09-17
00841824105034N/AW.H.P.M. INC.JXN2023-02-14
00869419000236Express ResultsTM Quest DiagnosticsJXN2022-03-28
00841824104853NAW.H.P.M. INC.JXN2021-10-12
10694644450740INCUPAMERICAN BIO MEDICA CORPORATIONJXN2021-06-24
00816036027160STATCUP® MICRO DISTRIBUTING, L.CJXN2021-01-14
00811727017918Pointe Propoxyphene (PPX) Reagent SetPOINTE SCIENTIFIC, INC.JXN2020-09-25
00811727017925Pointe Propoxyphene (PPX) Reagent SetPOINTE SCIENTIFIC, INC.JXN2020-09-25
10694644150459Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2020-05-29
07613336166116Propoxyphene PlusRoche Diagnostics GmbHJXN2020-03-05
00841824101920ECO® II CupW.H.P.M. INC.JXN2020-01-17
00380740165307AlinityABBOTT LABORATORIESJXN2019-10-10
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2019-10-03
00850798007787CSITRANSMED CO, LLCJXN2019-10-01
20816490022941HealgenHealgen Scientific Limited Liability CompanyJXN2019-07-31
20816490022866HealgenHealgen Scientific Limited Liability CompanyJXN2019-07-29
00841824104334ECO® II CupW.H.P.M. INC.JXN2019-07-10
00816036026569STATCUP® MICRO DISTRIBUTING, L.CJXN2019-07-02
00812203030148GenericCHEMTRON BIOTECH INCJXN2019-04-29
00817763022428FIRST SIGN®HEMOSURE INC.JXN2019-04-29
20850721007888Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCJXN2019-04-18
00817815020259CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.JXN2019-03-18
00858886006322Noble 1 Step CupNOBLE MEDICAL INCJXN2019-01-24
00855944007383Easy@Home 9 Panel Instant Urine Drug Test (2 test kit)EASY HEALTHCARE CORPORATIONJXN2018-06-26
20816490021883HealgenHealgen Scientific Limited Liability CompanyJXN2018-04-24
00851950008154ArvolifeClinical GuardJXN2018-03-26
00630414595948Atellica CH PpxSiemens Healthcare Diagnostics Inc.JXN2017-12-22
00816036025623STATDIP®MICRO DISTRIBUTING, L.CJXN2017-12-04
00816036025920STATDIP®MICRO DISTRIBUTING, L.CJXN2017-12-04
20612479215393McKessonMCKESSON MEDICAL-SURGICAL INC.JXN2017-08-02