FDA.reportPublic FDA data

CRL STAT Dip Card

Primary DI
00817815020693
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
2022-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817815020709PrimaryGS10
00817815020693Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817815020709008178150207098178150207090817815020709
00817815020693008178150206938178150206930817815020693

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
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 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

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Primary DI, Brand, Company table
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06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFT2026-10-13
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-08-14
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06936983114455Alltest AMP500 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
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