DEVICE: GLYCOMARK (04987170775586)
Device Identifier (DI) Information
GLYCOMARK
NK-8330
In Commercial Distribution
NIPPON KAYAKU CO., LTD.
NK-8330
In Commercial Distribution
NIPPON KAYAKU CO., LTD.
Controls
1,5-anhydroglucitol (1,5-AG)
Enzymatic 1,5-AG Assay for Glycemic Control
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
45731 | 1,5-Anhydroglucitol IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of 1,5-anhydroglucitol 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 [?] |
---|---|
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 |
---|
Device Size Text, specify: 3 Vials, 2 Milliliter each (Low Control) |
Device Size Text, specify: 3 Vials, 2 Milliliter each (High Control) |
Device Record Status
1877352c-ccf8-40c9-98d2-f4fb94999a37
December 22, 2020
5
September 24, 2016
December 22, 2020
5
September 24, 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
[?]
8887440221
info@precisiondiabetesinc.com
info@precisiondiabetesinc.com