TRUE+ A1CNow Self Check C8H01-02

GUDID 10021292015029

The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.

POLYMER TECHNOLOGY SYSTEMS, INC.

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use

• Primary Device ID: 10021292015029
• NIH Device Record Key: aeb1a1de-a2dd-49e4-ae70-56f3a5c07d24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUE+ A1CNow Self Check
• Version Model Number: C8H01-02
• Catalog Number: C8H01-02
• Company DUNS: 835772872
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00021292015022 [Primary]
GS1	10021292015029 [Package]; Contains: 00021292015022; Package: case [24 Units]; In Commercial Distribution
GS1	20021292015026 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090413

FDA Product Code

• LCP: ASSAY, GLYCOSYLATED HEMOGLOBIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-07
• Device Publish Date: 2023-07-30

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• 10021292015029 - TRUE+ A1CNow Self Check: 2023-08-07 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev
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