Hemosure® Accu-Reader®

GUDID 00817763022770

Hemosure® Accu-Reader® A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader® A100 is comprised of Hemosure® Accu-Reader® A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader® A100 Control and Hemosure® Accu-Reader® A100 Calibration Cartridge Kit.

W.H.P.M. INC.

Faecal occult blood IVD, kit, rapid ICT, clinical

• Primary Device ID: 00817763022770
• NIH Device Record Key: 5793e71a-560d-4408-8bce-b5ceac8abe5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemosure® Accu-Reader®
• Version Model Number: A100
• Company DUNS: 602085672
• Company Name: W.H.P.M. 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817763022770 [Primary]

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: 2023-05-18
• Device Publish Date: 2023-05-10

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