DEVICE: Dako (05700572014294)
Device Identifier (DI) Information
Dako
X0974
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0974
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Cystatin C Calibrator
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
48174 | Cystatin C IVD, calibrator |
A material which is used to establish known points of reference for an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJX | Single (specified) analyte controls (assayed and unassayed) |
NDY | TEST, CYSTATIN C |
JIT | CALIBRATOR, SECONDARY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 1 Milliliter |
Device Record Status
aea85d5b-e9b5-4b02-a258-c961cb67cc22
December 07, 2020
6
September 16, 2016
December 07, 2020
6
September 16, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+4544859500
dako.dkregulatory@agilent.com
dako.dkregulatory@agilent.com