DEVICE: A1CNow®+ Multi-UseTest System (20 count) (00381933021011)

Device Identifier (DI) Information

A1CNow®+ Multi-UseTest System (20 count)
3021
In Commercial Distribution
3021
POLYMER TECHNOLOGY SYSTEMS, INC.
00381933021011
GS1

20
835772872 *Terms of Use
The A1CNow®+ Multi-Use 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
Yes
No
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, point-of-care A collection of devices including a portable, battery-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. 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: If refrigerated, ensure components are at room temperature prior to use.
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit
Special Storage Condition, Specify: Product may be stored for a total of four months at room temperature (18-25 degrees C) anytime before the expiration date.
Special Storage Condition, Specify: If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f7e54125-fc90-4ee3-8045-5e2fe2ce1056
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: 10381933021018 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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