DEVICE: EliA IgM Curve Control Strip (07333066012988)
Device Identifier (DI) Information
EliA IgM Curve Control Strip
83-0006-31
In Commercial Distribution
83-0006-31
Phadia AB
83-0006-31
In Commercial Distribution
83-0006-31
Phadia AB
EliA IgM Curve Control Strip
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Total immunoglobulin M (IgM 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 M (IgM total) in a clinical specimen, using an enzyme immunoassay (EIA) method. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJY | Multi-analyte controls, all kinds (assayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K091845 | 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
94d0af64-c4c7-433e-93b8-4eb7ae7a0664
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 |
---|---|---|---|---|---|
07333066013978 | 6 | 07333066012988 | 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