CRL STAT Dip Card

GUDID 00817815020358

DOA 10 in 1 Test CRL Stat Dip Card, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET1000 MTD300 OPI2000 OXY100 PCP25 THC50

CLINICAL REFERENCE LABORATORY, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817815020358
NIH Device Record Keyde0ff47c-7d79-4b01-84f9-dcfd446308d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRL STAT Dip Card
Version Model NumberKCUR920085
Company DUNS098268311
Company NameCLINICAL REFERENCE LABORATORY, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817815020341 [Unit of Use]
GS100817815020358 [Primary]

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-26
Device Publish Date2019-03-18

On-Brand Devices [CRL STAT Dip Card]

00817815020419DOA 11 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300
00817815020396DOA 5 in 1 Test CRL Stat Dip Card, CLIA Waived, Sealed Pouch, AMP1000 COC300 OPI2000 PCP25 THC5
00817815020372DOA 5 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP500 COC150 MET500 OPI2000 TH
00817815020358DOA 10 in 1 Test CRL Stat Dip Card, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET100
00817815020334DOA 9 in 1 Test CRL Stat Dip Card, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET1000
00817815020693CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PC
00817815020778CRL STAT 12 Panel Dip -KCUR920124 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OX
00817815020907CRL STAT 8 Panel Dip - KCUR920121 AMP1000/BAR300/BZO300/COC300/MET1000/OPI2000/PCP25/THC50 (CR/N
00817815020969CRL STAT 9 Panel Dip - KCUR920075 AMP1000/BAR300/BZO300/COC300/MET 1000/MTD300/OPI2000/PCP25/THC
00817815021447CRL STAT 12 Panel Dip -KCUR920124 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OX
00817815021294CRL STAT 5 panel Dip - KCUR920106 AMP1000/COC300/OPI2000/PCP25/THC50
00817815021263CRL STAT 5 panel Dip - KCUR920102 AMP500/COC150/MET500/OPI2000/THC50 (pH/SG/OX/CR/NI)
00817815021201CRL STAT 10 panel Dip - KCUR920085 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PC
00817815021140CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PC

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