DEVICE: AU (15099590012120)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| 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? |
|---|---|---|---|---|
| 59090 | Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) in a clinical specimen, using a nephelometry/turbidimetry method.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| PDJ | Hemoglobin A1c Test System |
| LCP | Assay, Glycosylated Hemoglobin |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Store at 2 to 8 degrees celcius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
b0cf24b8-d07d-49a8-9da8-5ab20d106480
March 11, 2019
1
February 13, 2019
March 11, 2019
1
February 13, 2019
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
[?]
No Customer Contact currently defined