FDA.report

TOX/See

Primary DI
00847817000591
Brand
TOX/See
Company
BIO-RAD LABORATORIES, INC.
Model
194-5200
Catalog number
1945200
Device description
TOX/See Drug Screen Test AMP, COC, OPI, PCP, 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

Related Records

Contact Domains

Product Codes

CodeName
DISENZYME IMMUNOASSAY, BARBITURATE

Product Code Classifications

CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847817000591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817000591008478170005918478170005910847817000591

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
10810173655726HealgenHealgen Scientific Limited Liability CompanyDIS2026-01-30
00810173654760HealgenHealgen Scientific Limited Liability CompanyDIS2026-01-08
10810173653951HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810173654057HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810173654675HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810124273849CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIS2024-12-17
10815845023155SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DIS2024-12-17
05055273216752Evidence MultiSTAT DOA Urine MultiPlexRANDOX LABORATORIES LIMITEDDIS2024-09-16
10817405024077iScreen™ Urine Test E-Z Split Key™ Drug Screen CupInstant Technologies, Inc.DIS2024-07-16
10810124273009SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)ALERE SAN DIEGO, INC.DIS2023-12-15
10810124273276SureStep™ Urine Test Drug Screen Cassette, Barbiturates (BAR 300)ALERE SAN DIEGO, INC.DIS2023-12-15
10810124273719CERTUM BAR One Step Barbiturates Test StripALERE SAN DIEGO, INC.DIS2023-12-15
16970429841342DTPMCo-Innovation Biotech Co., LtdDIS2023-12-08
00817815021089CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.DIS2023-08-23
00817815021324CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.DIS2023-08-23
10690286000770PROFILE®-IIAMEDTOX DIAGNOSTICS, INC.DIS2023-06-01
10817405022806iCup™Instant Technologies, Inc.DIS2023-02-06
10817405023049iCup™Instant Technologies, Inc.DIS2023-02-06
30817405021476iScreen™Instant Technologies, Inc.DIS2023-02-01
B298608040DrugCheckExpress Diagnostic Int'l, Inc.DIS2022-10-14
B298610700DrugCheckExpress Diagnostic Int'l, Inc.DIS2022-07-22
00811727017178Pointe Barbiturate Reagent SetPOINTE SCIENTIFIC, INC.DIS2020-09-25
00811727017185Pointe Barbiturate Reagent SetPOINTE SCIENTIFIC, INC.DIS2020-09-25
10690286000701EZ-SCREEN® CUPMEDTOX DIAGNOSTICS, INC.DIS2020-08-04
07613336121030ONLINE DAT Barbiturates PlusRoche Diagnostics GmbHDIS2020-03-05
00860113002021MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002038MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002045MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002052MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
B29830150C10DrugCheckExpress Diagnostic Int'l, Inc.DIS2019-12-31