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 Issuing Agency | Device ID |
---|---|
GS1 | 00817763022770 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-18 |
Device Publish Date | 2023-05-10 |
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 |
00817763022770 - Hemosure® Accu-Reader® | 2023-05-18Hemosure® 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. |
00817763022770 - Hemosure® Accu-Reader® | 2023-05-18 Hemosure® Accu-Reader® A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detect |
00841824101708 - ECO II Cup | 2023-03-01 DOA 12 in 1 Test ECO II Cup W/ AD, 25Pcs/Box ,CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP500/MDMA/MTD/MOR/OXY/PCP/TCA/PH-CR-OX |
00817763022787 - First Sign® | 2023-02-22 DOA 9 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY |
00841824105034 - N/A | 2023-02-22 DOA 13 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY/PCP/PPX/TCA/THC |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEMOSURE 86522031 4808031 Live/Registered |
Hemosure Inc. 2015-02-02 |
HEMOSURE 85476877 not registered Dead/Abandoned |
Hemosure, Inc. 2011-11-18 |
HEMOSURE 78310205 2899814 Live/Registered |
Hemosure Inc. 2003-10-07 |
HEMOSURE 76160618 not registered Dead/Abandoned |
Wan, John 2000-11-07 |
HEMOSURE 75403437 not registered Dead/Abandoned |
LaPointe, Lawrence C. 1997-12-08 |