CRL STAT KCUR920127

GUDID 00817815020730

DOA 4 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box AMP1000/COC300/MET1000/OPI2000

W.H.P.M. INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00817815020730
• NIH Device Record Key: 7cda3a23-a0eb-4449-bb76-4cb406a1c6d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRL STAT
• Version Model Number: KCUR920127
• Catalog Number: KCUR920127
• Company DUNS: 602085672
• Company Name: W.H.P.M. 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817815020730 [Unit of Use]
GS1	00817815020747 [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: 2022-11-30
• Device Publish Date: 2022-11-22

Devices Manufactured by W.H.P.M. INC.

• 00841824105553 - ECOII: 2024-08-30 DOA 14 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/PPX/TCA/THC
• 00841824104730 - EZ CLICK: 2024-08-02 DOA 12 in 1 Test EZ CLICK Cup W/ AD, 25Pcs/Box, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC/PH-SG-OX
• 00841824105409 - N/A: 2024-06-24 DOA 7 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, BUP/BZO/COC/mAMP/MTD/OPI/OXY
• 00841824105492 - ECOII: 2024-05-06 DOA 10 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC/SG-PH-CR
• 00841824105454 - N/A: 2024-04-16 DOA 9 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived AMP/BARB/BUP/BZO/COC/MTD/OPI/OXY/THC
• 00841824105348 - ECOII: 2023-06-23 DOA 10 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BUP/BZO/COC/EDDP/mAMP/MTD/OPI/OXY/THC
• 00841824105249 - ECOII: 2023-05-26 DOA 11 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP
• 00841824105300 - ECOII: 2023-05-26 DOA 4 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived, AMP/COC/OPI/PCP/CR-NI-OX-PH-SG