Chromogenic Optic (Advance) 00009757980

GUDID 08426950452768

KIT,CHROM OPTIC TEST 160MMOL L,FUTU ADVA

INSTRUMENTATION LABORATORY COMPANY

Optical instrument calibration/verification solution IVD Optical instrument performance standard calibrator/control IVD, single-use
Primary Device ID08426950452768
NIH Device Record Key73706e91-0884-4002-866c-dd75a8e3b860
Commercial Distribution StatusIn Commercial Distribution
Brand NameChromogenic Optic (Advance)
Version Model Number00009757980
Catalog Number00009757980
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950452768 [Primary]

FDA Product Code

JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-05
Device Publish Date2016-09-23

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