A1CNow® Self Check Test System 3070

GUDID 00381933070019

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: 00381933070019
• NIH Device Record Key: f51811cd-7539-49c6-87b1-6253e129a1b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A1CNow® Self Check Test System
• Version Model Number: 3070
• Catalog Number: 3070
• Company DUNS: 835772872
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Device Count: 4
• 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(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381933070019 [Primary]
GS1	10381933070016 [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: 2018-09-10
• Device Publish Date: 2018-08-10

On-Brand Devices [A1CNow® Self Check Test System]

• 00381933070019: The A1CNow® Self Check Test System provides quantitative measurement of the percent of glycated
• 00381933030013: The A1CNow® Self Check Test System provides quantitative measurement of the percent of glycated