DEVICE: A1CNow® Self Check Test System (00381933030013)

Device Identifier (DI) Information

A1CNow® Self Check Test System
3030
In Commercial Distribution
3030
POLYMER TECHNOLOGY SYSTEMS, INC.
00381933030013
GS1

2
835772872 *Terms of Use
The A1CNow® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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

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Product Code Product Code Name
LCP ASSAY, GLYCOSYLATED HEMOGLOBIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090413 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight.
Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 18 and 25 Degrees Celsius
Special Storage Condition, Specify: Do not use if dot is red or if the product is past the expiration date.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0e6e5450-8a97-4fbe-b048-ce7e09707c5e
July 06, 2018
3
August 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 10381933030010 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(888)870-5610
customerservice@ptsdiagnostics.com
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