WOUNDCHEK™ Bacterial Status

GUDID 10811877011245

Intended for the assessment of bacterial protease activity in chronic wounds.

Alere Scarborough, Inc.

Protease IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10811877011245
NIH Device Record Key7b9cc812-387a-4954-b956-7cee754fe7da
Commercial Distribution StatusIn Commercial Distribution
Brand NameWOUNDCHEK™ Bacterial Status
Version Model Number360006US
Company DUNS154148498
Company NameAlere Scarborough, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110811877011245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFAAssay For Detection Of Proteases In Chronic Wounds

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-03
Device Publish Date2020-05-26

Devices Manufactured by Alere Scarborough, Inc.

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Trademark Results [WOUNDCHEK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WOUNDCHEK
WOUNDCHEK
85413291 4238917 Live/Registered
WOUNDCHECK LABORATORIES HOLDINGS, INC.
2011-09-01
WOUNDCHEK
WOUNDCHEK
85066668 not registered Dead/Abandoned
Systagenix Wound Management (US), Inc.
2010-06-18

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