ISOSTAT® Consumables

GUDID 10811877010064

Consumables needed for processing ISOLATOR 10 mL Microbial Tubes for adults.

Alere Scarborough, Inc.

Fluid transfer set, general-purpose
Primary Device ID10811877010064
NIH Device Record Key7d27aebf-f32a-4304-a515-65956943dc5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameISOSTAT® Consumables
Version Model Number50C9
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
GS110811877010064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-19
Device Publish Date2016-09-05

Devices Manufactured by Alere Scarborough, Inc.

00811877012030 - BinaxNOW COVID-19/Flu A&B Combo Self Test2025-02-07 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 Test2025-02-07 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 Test2025-02-07 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 Test2025-02-07 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 Test2025-02-07 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 Test2025-02-07 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 Controls2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

Trademark Results [ISOSTAT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISOSTAT
ISOSTAT
80976644 0976644 Dead/Cancelled
Parke, Davis & Company
0000-00-00
ISOSTAT
ISOSTAT
75177999 not registered Dead/Abandoned
Vi-Jon Laboratories, Inc.
1996-10-07
ISOSTAT
ISOSTAT
74306355 1854108 Live/Registered
ILLINOIS TOOL WORKS INC.
1992-08-19
ISOSTAT
ISOSTAT
73476694 1343998 Live/Registered
E. I. DU PONT DE NEMOURS AND COMPANY
1984-04-23

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