CRL Stat Dip Card KCUR920082

GUDID 00817815020686

DOA 11 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box AMP1000 BAR300 BZO300 COC300 MET1000 MTD300 OPI2000 OXY100 PCP25 PPX300 THC50 & pH SG OX CR NI

W.H.P.M. INC.

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

• Primary Device ID: 00817815020686
• NIH Device Record Key: 78ba4bf0-53f3-494d-9f7f-63f10ebc08e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRL Stat Dip Card
• Version Model Number: KCUR920082
• Catalog Number: KCUR920082
• Company DUNS: 602085672
• Company Name: W.H.P.M. INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817815020686 [Unit of Use]
GS1	10817815020683 [Primary]

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-02
• Device Publish Date: 2021-08-25

On-Brand Devices [CRL Stat Dip Card]

• 00817815020471: DOA 8 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 MET1000 BAR300 BZO300
• 00817815020686: DOA 11 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box AMP1000 BAR300 BZO300 COC300 MET1000