FDA.reportPublic FDA data

CRL STAT Cup

Primary DI
00817815020075
Brand
CRL STAT Cup
Company
CLINICAL REFERENCE LABORATORY, INC.
Model
KCUR920079
Device description
DOA 5 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, COC300 MET1000 OPI2000 PCP25 THC50 & pH SG OX CR NI
Published
2019-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817815020075PrimaryGS10
00817815020068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817815020075008178150200758178150200750817815020075
00817815020068008178150200688178150200680817815020068

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098268311
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817815021010CRL STAT CupKCUR9200772023-08-23
00817815021027CRL STAT CupKCUR9200792023-08-23
00817815021058CRL STAT CupKCUR9200802023-08-23
00817815021089CRL STAT CupKCUR9200812023-08-23
00817815021119CRL STAT CupKCUR9200832023-08-23
00817815021140CRL STAT Dip CardKCUR9200842023-08-23
00817815021171CRL STAT CupKCUR9200922023-08-23
00817815021201CRL STAT Dip CardKCUR9200852023-08-23
00817815021232CRL STAT CupKCUR9200962023-08-23
00817815021263CRL STAT Dip CardKCUR9201022023-08-23
00817815021294CRL STAT Dip CardKCUR9201062023-08-23
00817815021324CRL STAT CupKCUR9201102023-08-23
00817815021355CRL STAT CupKCUR9201152023-08-23
00817815021386CRL STAT CupKCUR9201192023-08-23
00817815021416CRL STAT CupKCUR9201202023-08-23
00817815021447CRL STAT Dip CardKCUR9201242023-08-23
00817815021478CRL STAT CupKCUR9201262023-08-23
00817815020938CRL STAT CupKCUR9200742023-08-21
00817815020969CRL STAT Dip CardKCUR9200752023-08-21
00817815020877CRL STAT CupKCUR9200822023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LCM2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LAF2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LAF2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLCM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLAF2026-07-31
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.DIO2026-07-07
00841824104167ECOIIW.H.P.M. INC.LAF2026-07-07
00841824104167ECOIIW.H.P.M. INC.LCM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
00810174471229Prime Screen®WONDFO USA CO., LTD.LCM2026-06-26
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03