DEVICE: ImmunoCAP Specific IgA Conjugate (07333066012230)
Device Identifier (DI) Information
ImmunoCAP Specific IgA Conjugate
34-2328-11
In Commercial Distribution
34-2328-11
Phadia AB
34-2328-11
In Commercial Distribution
34-2328-11
Phadia AB
ImmunoCAP Specific IgA Conjugate
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 |
---|---|
MST | Antibodies, gliadin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K052793 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do not freeze! |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d317e2c9-a206-4020-8a49-acaece3615c2
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 |
---|---|---|---|---|---|
07333066000510 | 1 | 07333066012230 | 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