FDA.reportPublic FDA data

Triage

Primary DI
30014613338109
Brand
Triage
Company
QUIDEL CARDIOVASCULAR INC.
Model
94600
Catalog number
94600
Device description
Triage TOX Drug Screen, 94600
Published
2019-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DISEnzyme immunoassay, barbiturate
DJGEnzyme immunoassay, opiates
DJREnzyme immunoassay, methadone
JXMEnzyme immunoassay, benzodiazepine
JXOEnzyme immunoassay, cocaine
KHOFLUOROMETER, FOR CLINICAL USE
LAFGas chromatography, methamphetamine
LDJEnzyme immunoassay, cannabinoids
LFGRadioimmunoassay, tricyclic antidepressant drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
JXOEnzyme Immunoassay, CocaineClinical Toxicology2
KHOFluorometer, For Clinical UseClinical Chemistry1
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613338109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333810930014613338109

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1103technicalsupport@quidel.com

Regulatory Flags#

DUNS number
080890141
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30014613337706Triage98200982002018-11-01
30014613337911Triage97000HS97000HS2018-11-01
30014613337935Triage97021HS97021HS2018-11-01
30014613337942Triage97022HS97022HS2018-11-01
30014613337980Triage98000XR98000XR2018-11-01
30014613338000Triage98100981002018-11-01
30014613338772Sofia20352203522025-11-18
50014613338776Sofia20352203522025-11-18
30014613337041Triage98713EU98713EU2018-11-07
30014613337713Triage98201982012018-11-01
30014613337720Triage98202982022018-11-01
30014613337959Triage97300EU97300EU2018-11-01
30014613337966Triage97400EU97400EU2018-11-01
30014613337973Triage97500EU97500EU2018-11-01
30014613337997Triage98000XREU98000XREU2018-11-01
30014613338017Triage98100EU98100EU2018-11-01
30014613338024Triage98600EU98600EU2018-11-01
30014613338116Triage94613946132019-07-24
30014613338123Triage94614946142019-07-24
30014613337010Triage98013XR98013XR2018-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817405024247iScreen™Instant Technologies, Inc.LFG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LAF2026-08-01
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIS2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLAF2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLFG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJR2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIS2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIS2026-07-07
00841824104167ECOIIW.H.P.M. INC.LAF2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJR2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03