Home GUDID 00847817000386 TOX/See
Primary DI 00847817000386
Brand TOX/See
Company BIO-RAD LABORATORIES, INC.
Model 194-5221
Catalog number 1945221
Device description TOX/See Drug Screen Test AMP, BAR, BZO, COC, MDMA, MET, MTD, OPI, OXY, PCP, TCA, THC
Published 2016-09-12
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 Code Name JXM Enzyme immunoassay, benzodiazepine
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00847817000386 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 00847817000386 00847817000386 847817000386 0847817000386
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 Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 132528295 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 true 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 10810173655993 Healgen Healgen Scientific Limited Liability Company JXM 2026-03-11 10810173655597 Healgen Healgen Scientific Limited Liability Company JXM 2026-02-04 10810173655658 Healgen Healgen Scientific Limited Liability Company JXM 2026-02-04 00810173655101 Healgen Healgen Scientific Limited Liability Company JXM 2026-01-31 10810173655603 Healgen Healgen Scientific Limited Liability Company JXM 2026-01-30 10810173655641 Healgen Healgen Scientific Limited Liability Company JXM 2026-01-30 00810173654821 Healgen Healgen Scientific Limited Liability Company JXM 2026-01-08 00810173654838 Healgen Healgen Scientific Limited Liability Company JXM 2026-01-08 00850054026989 QMedix™ Diagnostic Automation, Inc. JXM 2025-12-23 00850054026996 QMedix™ Diagnostic Automation, Inc. JXM 2025-12-23 10810173654002 Healgen Healgen Scientific Limited Liability Company JXM 2025-12-19 10810173654149 Healgen Healgen Scientific Limited Liability Company JXM 2025-12-19 10810173654644 Healgen Healgen Scientific Limited Liability Company JXM 2025-12-19 00850013035830 Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INC JXM 2025-12-04 00817038022252 10 Panel Drug Test Cup UCP BIOSCIENCES, INC. JXM 2025-03-24 10815845024305 SureStep™ Urine Test Drug Screen Strip ALERE SAN DIEGO, INC. JXM 2024-12-17 00841824105409 N/A W.H.P.M. INC. JXM 2024-06-14 10810124273023 SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300) ALERE SAN DIEGO, INC. JXM 2023-12-15 10810124273283 SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300) ALERE SAN DIEGO, INC. JXM 2023-12-15 10810124273726 CERTUM BZO One Step Benzodiazepines Test Strip ALERE SAN DIEGO, INC. JXM 2023-12-15 00817763022367 First Sign HEMOSURE INC. JXM 2023-05-18 04015630999347 ONLINE DAT Benzodiazepines II Roche Diagnostics GmbH JXM 2023-05-11 07613336121054 ONLINE DAT Benzodiazepines II Roche Diagnostics GmbH JXM 2023-05-11 00850041101750 Onsite DrugScreen Medical Disposables Corp JXM 2023-04-24 00850041101781 Onsite DrugScreen Medical Disposables Corp JXM 2023-04-24 00850041101798 Onsite DrugScreen Medical Disposables Corp JXM 2023-04-24 10817405022936 iCup™ Instant Technologies, Inc. JXM 2023-02-09 30817405022282 iScreen™ Instant Technologies, Inc. JXM 2023-02-07 30817405022565 iCassette™ Instant Technologies, Inc. JXM 2023-02-07 B77830573OD0 Origin Instant Dip Drug Test ORIGIN DIAGNOSTICS LLC JXM 2022-12-07
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