DEVICE: CVS Health At Home A1C Test Kit (00050428526859)
Device Identifier (DI) Information
CVS Health At Home A1C Test Kit
3059
In Commercial Distribution
3059
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
3059
In Commercial Distribution
3059
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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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? |
|---|---|---|---|---|
| 62205 | Glycated haemoglobin (HbA1c) monitoring system IVD, home-use |
A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.
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FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LCP | Assay, Glycosylated Hemoglobin |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K090413 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify: Store out of direct sunlight. |
| Special Storage Condition, Specify: Do not use if dot is red or if the product is past the expiration date. |
| Special Storage Condition, Specify: Use indoors at room temperature. |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
e0eac44a-41cb-4b5e-be3d-1914a3631e5e
July 06, 2018
3
October 17, 2016
July 06, 2018
3
October 17, 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:
10050428526856
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-746-7287
xx@xx.xx
xx@xx.xx