Home GUDID 20816490020787 Healgen
Primary DI 20816490020787
Brand Healgen
Company Healgen Scientific Limited Liability Company
Model HCDOAV-2125
Catalog number HCDOAV-2125
Device description 12 Panel DOA Test clear Round Cup With Clicker;
Published 2016-12-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name JXN Enzyme Immunoassay, Propoxyphene
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10816490020780 Package GS1 25 In Commercial Distribution 20816490020787 Package GS1 4 In Commercial Distribution 00816490020783 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10816490020780 10816490020780 20816490020787 20816490020787 00816490020783 00816490020783 816490020783 0816490020783
GMDN Terms# Term, Definition table Term Definition Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 031802328 Device count 1 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10810124273672 SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup ALERE SAN DIEGO, INC. JXN 2024-09-17 00841824105034 N/A W.H.P.M. INC. JXN 2023-02-14 00869419000236 Express ResultsTM Quest Diagnostics JXN 2022-03-28 00841824104853 NA W.H.P.M. INC. JXN 2021-10-12 10694644450740 INCUP AMERICAN BIO MEDICA CORPORATION JXN 2021-06-24 00816036027160 STATCUP® MICRO DISTRIBUTING, L.C JXN 2021-01-14 00811727017918 Pointe Propoxyphene (PPX) Reagent Set POINTE SCIENTIFIC, INC. JXN 2020-09-25 00811727017925 Pointe Propoxyphene (PPX) Reagent Set POINTE SCIENTIFIC, INC. JXN 2020-09-25 10694644150459 Rapid TOX AMERICAN BIO MEDICA CORPORATION JXN 2020-05-29 07613336166116 Propoxyphene Plus Roche Diagnostics GmbH JXN 2020-03-05 00841824101920 ECO® II Cup W.H.P.M. INC. JXN 2020-01-17 00380740165307 Alinity ABBOTT LABORATORIES JXN 2019-10-10 10694644200505 RTCII 1st gen. AMERICAN BIO MEDICA CORPORATION JXN 2019-10-03 00850798007787 CSI TRANSMED CO, LLC JXN 2019-10-01 20816490022941 Healgen Healgen Scientific Limited Liability Company JXN 2019-07-31 20816490022866 Healgen Healgen Scientific Limited Liability Company JXN 2019-07-29 00841824104334 ECO® II Cup W.H.P.M. INC. JXN 2019-07-10 00816036026569 STATCUP® MICRO DISTRIBUTING, L.C JXN 2019-07-02 00812203030148 Generic CHEMTRON BIOTECH INC JXN 2019-04-29 00817763022428 FIRST SIGN® HEMOSURE INC. JXN 2019-04-29 20850721007888 Identify Diagnostics USA MEDICAL DISTRIBUTION GROUP INC JXN 2019-04-18 00817815020259 CRL STAT Cup CLINICAL REFERENCE LABORATORY, INC. JXN 2019-03-18 00858886006322 Noble 1 Step Cup NOBLE MEDICAL INC JXN 2019-01-24 00855944007383 Easy@Home 9 Panel Instant Urine Drug Test (2 test kit) EASY HEALTHCARE CORPORATION JXN 2018-06-26 20816490021883 Healgen Healgen Scientific Limited Liability Company JXN 2018-04-24 00851950008154 Arvolife Clinical Guard JXN 2018-03-26 00630414595948 Atellica CH Ppx Siemens Healthcare Diagnostics Inc. JXN 2017-12-22 00816036025623 STATDIP® MICRO DISTRIBUTING, L.C JXN 2017-12-04 00816036025920 STATDIP® MICRO DISTRIBUTING, L.C JXN 2017-12-04 20612479215393 McKesson MCKESSON MEDICAL-SURGICAL INC. JXN 2017-08-02
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