CRLstat Monitect X04-PC12

GUDID 00817815021003

5 Multi-Drug Screen Panel, OPI2000/MET1000/THC50/COC300/PCP25 Cassette Tests

CLINICAL REFERENCE LABORATORY, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00817815021003
• NIH Device Record Key: e33935ef-074f-4329-9400-04fd692ba31e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRLstat Monitect
• Version Model Number: X04-PC12
• Catalog Number: X04-PC12
• Company DUNS: 098268311
• Company Name: CLINICAL REFERENCE LABORATORY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx
• Phone: 1-800-445-6917
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817815021003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K004034

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-06

Devices Manufactured by CLINICAL REFERENCE LABORATORY, INC.

• 00817815021010 - CRL STAT Cup: 2023-08-31 CRL STAT 9 panel Cup - KCUR920077 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/PCP25/THC50
• 00817815021027 - CRL STAT Cup: 2023-08-31 CRL STAT 5 panel Cup - KCUR920079 COC300/MET1000/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
• 00817815021058 - CRL STAT Cup: 2023-08-31 CRL STAT 9 panel Cup - KCUR920080 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
• 00817815021089 - CRL STAT Cup: 2023-08-31 CRL STAT 7 panel Cup - KCUR920081 BAR300/BZO300/COC300/MET1000/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
• 00817815021119 - CRL STAT Cup: 2023-08-31 CRL STAT 10 panel Cup - KCUR920083 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50 (pH/SG/OX/CR/NI)
• 00817815021140 - CRL STAT Dip Card: 2023-08-31 CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
• 00817815021171 - CRL STAT Cup: 2023-08-31 CRL STAT 12 Panel Cup - KCUR920092 AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MTD300/OPI300/OXY100/PCP25/THC50 (SG/CR/O
• 00817815021201 - CRL STAT Dip Card: 2023-08-31 CRL STAT 10 panel Dip - KCUR920085 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50