DEVICE: Autokit Micro Albumin Calibrator Set (00856626006106)
Device Identifier (DI) Information
Autokit Micro Albumin Calibrator Set
995-06101
Not in Commercial Distribution
995-06101
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-06101
Not in Commercial Distribution
995-06101
FUJIFILM WAKO PURE CHEMICAL CORPORATION
In-Vitro Diagnostic Use
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? |
---|---|---|---|---|
53477 | Microalbumin IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K030320 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
32321d3e-8593-40e3-ba02-7e8cee2d8ff1
October 26, 2020
5
December 07, 2016
October 26, 2020
5
December 07, 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
[?]
877-714-1924
diagnostics@wakousa.com
diagnostics@wakousa.com