CRL STAT Cup

GUDID 00817815020297

DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP500 BAR300 BZO300 COC150 MET500 MTD300 OPI2000 OXY100 PCP25 THC50 & OX SG pH CR NI

CLINICAL REFERENCE LABORATORY, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817815020297
NIH Device Record Key21e1f85b-232c-49b7-ad48-16eb96f83c5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRL STAT Cup
Version Model NumberKCUR920115
Company DUNS098268311
Company NameCLINICAL REFERENCE LABORATORY, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817815020280 [Unit of Use]
GS100817815020297 [Primary]

FDA Product Code

DJREnzyme Immunoassay, Methadone

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 Cup]

00817815020433DOA 7 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 MET1000 COC300 THC50 OPI2000 PCP2
00817815020457DOA 9 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, COC300 OPI2000 AMP1000 MET1000 PCP2
00817815020310DOA 13 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BARB300 BZO300 BUP10 COC300 THC5
00817815020297DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP500 BAR300 BZO300 COC150 MET500
00817815020273DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MDMA5
00817815020259DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MDMA500 MET10
00817815020235DOA 11 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET500 MTD3
00817815020211DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, mAMP1000 COC300 THC50 AMP1000 OPI2
00817815020198DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP500 COC150 MDMA500 MET500 OPI200
00817815020174DOA 6 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 COC300 MET500 OPI2000 PCP25
00817815020150DOA 12 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, THC50 COC300 OPI300 AMP1000 mAMP10
00817815020136DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET100
00817815020112DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MET1000 OPI200
00817815020099DOA 9 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET100
00817815020075DOA 5 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, COC300 MET1000 OPI2000 PCP25 THC50
00817815020051DOA 9 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET1000 MTD3
00817815020037DOA 7 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MET1000 OPI2000 PCP2
00817815020013DOA 5 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box COC300 MET1000 OPI2000 PCP25 THC50
00817815020655CRL STAT 10 panel Cup - KCUR920126 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/O
00817815020877CRL STAT 11 Panel Cup- KCUR920082 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP
00817815020938CRL STAT 5 panel Cup- KCUR920074 COC300/MET1000/OPI2000/PCP25/THC50
00817815021478CRL STAT10 panel Cup - KCUR920126 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OX
00817815021416CRL STAT 9 Panel Cup - KCUR920120 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP
00817815021386CRL STAT 13 Panel Cup - KCUR920119 AMP1000/BAR 300/BUP10/BZO300/COC300/MAMP1000/MDMA500/MTD300/O
00817815021355CRL STAT 10 panel Cup-KCUR920115 AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/
00817815021324CRL STAT 10 panel Cup - KCUR920110 BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI300/OXY100/PCP
00817815021232CRL STAT 7 panel Cup - KCUR920096 AMP500/COC150/MDMA500/MET500/OPI2000/PCP25/THC50 (pH/SG/OX/CR/
00817815021171CRL STAT 12 Panel Cup - KCUR920092 AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MTD300/OP
00817815021119CRL STAT 10 panel Cup - KCUR920083 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PC
00817815021089CRL STAT 7 panel Cup - KCUR920081 BAR300/BZO300/COC300/MET1000/OPI2000/PCP25/THC50 (pH/SG/OX/CR/
00817815021058CRL STAT 9 panel Cup - KCUR920080 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/PCP25/THC5
00817815021027CRL STAT 5 panel Cup - KCUR920079 COC300/MET1000/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
00817815021010CRL STAT 9 panel Cup - KCUR920077 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/PCP25/THC5
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