DIASTAT anti-Mitochondrial FMIT200

GUDID 07340058410417

Euro-Diagnostica AB

Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07340058410417
NIH Device Record Key63fb0283-edcb-4b90-93ae-5dac20f77908
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIASTAT anti-Mitochondrial
Version Model NumberFMIT200
Catalog NumberFMIT200
Company DUNS559894501
Company NameEuro-Diagnostica AB
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107340058410417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-12

Devices Manufactured by Euro-Diagnostica AB

07340058410004 - DIASTAT anti-Ro (SS-A)2018-07-06
07340058410011 - DIASTAT anti-La (SS-B)2018-07-06
07340058410035 - DIASTAT anti-dsDNA2018-07-06
07340058410059 - DIASTST anti-Sm2018-07-06
07340058410110 - DIASTAT anti-thyroglobulin2018-07-06
07340058410134 - DIASTAT anti-Thyroid Peroxidase2018-07-06
07340058410417 - DIASTAT anti-Mitochondrial2018-07-06
07340058410417 - DIASTAT anti-Mitochondrial2018-07-06
07340058410431 - CCPoint2018-07-06

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