DEVICE: DIASTAT anti-Mitochondrial (07340058410417)
Device Identifier (DI) Information
DIASTAT anti-Mitochondrial
FMIT200
In Commercial Distribution
FMIT200
Euro-Diagnostica AB
FMIT200
In Commercial Distribution
FMIT200
Euro-Diagnostica AB
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
55032 | Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies to mitochondria M2 (anti-Mi2) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K921183 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
63fb0283-edcb-4b90-93ae-5dac20f77908
July 06, 2018
3
August 12, 2016
July 06, 2018
3
August 12, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined