FDA.reportPublic FDA data

CRL STAT Dip Card

Primary DI
00817815021140
Brand
CRL STAT Dip Card
Company
CLINICAL REFERENCE LABORATORY, INC.
Model
KCUR920084
Device description
CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QBFTest, Propoxyphene, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QBFTest, Propoxyphene, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817815021140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817815021140008178150211408178150211400817815021140

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098268311
Device count
1
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
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
00817815020907CRL STAT Dip CardKCUR9201212023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
10197344170203MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-29
10197344170210MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-23
10722066011260Rapid ResponseBTNX IncNFW2026-01-19
10722066011260Rapid ResponseBTNX IncNFV2026-01-19
10722066011260Rapid ResponseBTNX IncNGM2026-01-19
10722066011260Rapid ResponseBTNX IncPTG2026-01-19
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011260Rapid ResponseBTNX IncNGG2026-01-19
10722066011260Rapid ResponseBTNX IncNGL2026-01-19
10722066011260Rapid ResponseBTNX IncPTH2026-01-19
10722066011260Rapid ResponseBTNX IncQBF2026-01-19
10722066011277Rapid ResponseBTNX IncPTH2026-01-19
10722066011277Rapid ResponseBTNX IncNGM2026-01-19
10722066011277Rapid ResponseBTNX IncNFW2026-01-19
10722066011277Rapid ResponseBTNX IncNGG2026-01-19
10722066011277Rapid ResponseBTNX IncNGL2026-01-19
10722066011277Rapid ResponseBTNX IncPTG2026-01-19
10722066011277Rapid ResponseBTNX IncQBF2026-01-19
10722066009083Rapid ResponseBTNX IncNFV2025-10-03
10722066009083Rapid ResponseBTNX IncNGG2025-10-03
10722066009083Rapid ResponseBTNX IncPTH2025-10-03
10722066009083Rapid ResponseBTNX IncNGL2025-10-03
10722066009083Rapid ResponseBTNX IncNGM2025-10-03
10722066009083Rapid ResponseBTNX IncNFW2025-10-03
10722066009083Rapid ResponseBTNX IncNFY2025-10-03
10722066009083Rapid ResponseBTNX IncPTG2025-10-03
10722066010973Rapid ResponseBTNX IncNFY2025-07-08
10722066010973Rapid ResponseBTNX IncNFV2025-07-08
10722066010973Rapid ResponseBTNX IncNFW2025-07-08