INS ELISA

GUDID 05400569000117

INS ELISA

Diasource Immunoassays S.A. SA

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Primary Device ID05400569000117
NIH Device Record Keyd35947cb-66e6-4ce6-b906-d1f2bac9798e
Commercial Distribution StatusIn Commercial Distribution
Brand NameINS ELISA
Version Model NumberKAP1251
Company DUNS458777323
Company NameDiasource Immunoassays S.A. SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS105400569000117 [Primary]

FDA Product Code

CFPRADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-20
Device Publish Date2020-01-10

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