DEVICE: EliA IgA Calibrator Well (07333066014654)
Device Identifier (DI) Information
EliA IgA Calibrator Well
DECC055160
In Commercial Distribution
DECC055160
Phadia AB
DECC055160
In Commercial Distribution
DECC055160
Phadia AB
EliA IgA Calibrator Well
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
53756 | Total immunoglobulin A (IgA total) 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 total immunoglobulin A (IgA total) in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVM | Autoantibodies, endomysial(tissue transglutaminase) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K062787 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
318bcba7-a595-484b-b91f-3fffcd5a8ec6
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 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 |
---|---|---|---|---|---|
07333066010694 | 4 | 07333066014654 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+469999999999
xx@xx.xx
xx@xx.xx