Primary Device ID | 10811877011245 |
NIH Device Record Key | 7b9cc812-387a-4954-b956-7cee754fe7da |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WOUNDCHEK™ Bacterial Status |
Version Model Number | 360006US |
Company DUNS | 154148498 |
Company Name | Alere Scarborough, 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 | false |
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 | 10811877011245 [Primary] |
QFA | Assay For Detection Of Proteases In Chronic Wounds |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-06-03 |
Device Publish Date | 2020-05-26 |
00811877012030 - BinaxNOW COVID-19/Flu A&B Combo Self Test | 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens |
00811877012047 - BinaxNOW COVID-19/Flu A&B Combo Self Test | 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens |
00811877012054 - BinaxNOW COVID-19/Flu A&B Combo Self Test | 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens |
00811877012061 - BinaxNOW COVID-19/Flu A&B Combo Self Test | 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens |
00811877012078 - BinaxNOW COVID-19/Flu A&B Combo Self Test | 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens |
00811877012085 - BinaxNOW COVID-19/Flu A&B Combo Self Test | 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens |
00811877012092 - BinaxNOW COVID-19/Flu A&B | 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens |
00811877012108 - BinaxNOW COVID-19/Flu A&B Controls | 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() WOUNDCHEK 85413291 4238917 Live/Registered |
WOUNDCHECK LABORATORIES HOLDINGS, INC. 2011-09-01 |
![]() WOUNDCHEK 85066668 not registered Dead/Abandoned |
Systagenix Wound Management (US), Inc. 2010-06-18 |