ISOSTAT® Press and Rack

GUDID 00811877010050

ISOSTAT® Press and Rack for the processing of ISOLATOR Microbial Tubes for adults.

Alere Scarborough, Inc.

Instrument/analyser test tube rack IVD Instrument/analyser test tube rack IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD Instrument/analyser specimen/reagent container carrier IVD
Primary Device ID00811877010050
NIH Device Record Key2e44a94a-6f48-444a-b3ae-1b719b28b315
Commercial Distribution StatusIn Commercial Distribution
Brand NameISOSTAT® Press and Rack
Version Model Number50C2
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100811877010050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-05

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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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