A1CNow® Self Check Test System 3030
GUDID 00381933030013
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 | 00381933030013 |
| NIH Device Record Key | 0e6e5450-8a97-4fbe-b048-ce7e09707c5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A1CNow® Self Check Test System |
| Version Model Number | 3030 |
| Catalog Number | 3030 |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| 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 *Do not use if dot is red or if the product is past the expiration date. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381933030013 [Primary] |
| GS1 | 10381933030010 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-05 |
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 |
Trademark Results [A1CNow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A1CNOW 85063294 3908062 Live/Registered |
POLYMER TECHNOLOGY SYSTEMS, INC. 2010-06-15 |
 A1CNOW 78237620 2808862 Dead/Cancelled |
BAYER HEALTHCARE LLC 2003-04-14 |
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