CRL Stat ™ KCUR920101

GUDID 00817815020983

DOA 10 in 1 Test CRL QuickScreen Cup W/AD, 25Pcs/Box; Without Security Label & No Disposable Gloves BAR/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/THC/PH-SG-OX CLIA Waived

CLINICAL REFERENCE LABORATORY, INC.

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

• Primary Device ID: 00817815020983
• NIH Device Record Key: d8cc8265-0d4f-4d6c-be09-d1490bc3f01d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRL Stat ™
• Version Model Number: KCUR920101
• Catalog Number: KCUR920101
• Company DUNS: 098268311
• Company Name: CLINICAL REFERENCE LABORATORY, INC.
• Device Count: 25
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817815020969 [Unit of Use]
GS1	00817815020983 [Primary]

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

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: 2018-05-31
• Device Publish Date: 2016-10-14

On-Brand Devices [CRL Stat ™]

• 00817815020990: DOA 5 in 1 Test CRL QuickScreen Cup W/AD, 25Pcs/Box; Without Security Label & No Disposable Glov
• 00817815020983: DOA 10 in 1 Test CRL QuickScreen Cup W/AD, 25Pcs/Box; Without Security Label & No Disposable Glo