FDA.report

TOX/See

Primary DI
00847817000751
Brand
TOX/See
Company
BIO-RAD LABORATORIES, INC.
Model
194-5204
Catalog number
1945204
Device description
TOX/See Drug Screen Test PPX
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

Related Records

Contact Domains

Product Codes

CodeName
JXNENZYME IMMUNOASSAY, PROPOXYPHENE

Product Code Classifications

CodeDeviceSpecialtyClass
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847817000751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817000751008478170007518478170007510847817000751

GMDN Terms

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 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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)224-6723diagcs@bio-rad.com

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

Primary DIBrandModelCatalogPublished
03610522231072Liquichek12015644120156442024-05-24
03610522231089Liquichek12015645120156452024-05-24
03610522231096Liquichek12015646120156462024-05-24
03610522231102Liquichek12015647120156472024-05-24
03610522231119Liquichek12015648120156482024-05-24
03610522231461InteliQ12015705120157052024-05-24
03610522231478InteliQ12015706120157062024-05-24
03610522231485InteliQ12015707120157072024-05-24
03610522231492InteliQ12015708120157082024-05-24
03610522231508InteliQ12015709120157092024-05-24
03610522354658Liquichek12019576120195762024-05-24
03610522354665InteliQ12019558120195582024-05-24
00847661004080Quest Diagnostics9559552023-10-09
03610520540916Quest Diagnostics9309302023-10-09
03610520540923Quest Diagnostics9359352023-10-09
03610520540930Quest Diagnostics9459452023-10-09
03610521168942Geenius72480724802023-07-28
03610522162239Geenius12012482120124822023-07-28
03610522162260Geenius12012484120124842023-07-28
03610522168064Geenius12012851120128512023-07-28

Other Devices Sharing Product Codes

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