A1CNow®+ Multi-UseTest System (20 count) 3021
GUDID 00381933021011
The A1CNow®+ Multi-Use 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, point-of-care| Primary Device ID | 00381933021011 |
| NIH Device Record Key | f7e54125-fc90-4ee3-8045-5e2fe2ce1056 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A1CNow®+ Multi-UseTest System (20 count) |
| Version Model Number | 3021 |
| Catalog Number | 3021 |
| Company DUNS | 835772872 |
| Company Name | POLYMER TECHNOLOGY SYSTEMS, INC. |
| Device Count | 20 |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)870-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)870-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com | |
| Phone | +1(888)877-5610 |
| customerservice@ptsdiagnostics.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | Between 0 and 0 *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. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381933021011 [Primary] |
| GS1 | 10381933021018 [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 | 4 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2016-08-05 |
Devices Manufactured by POLYMER TECHNOLOGY SYSTEMS, INC.
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| 10381933080015 - A1CNow Self Check, 8ct. | 2023-11-02 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev |
| 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 |
| 10381932488010 - Assy Vial, eGLU, 13 ct. | 2023-08-07 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who |
| 10381934753017 - Lipid Panel, 15ct., CCPlus Home | 2023-06-28 CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL |
| 10381934755011 - eGLU, 15ct., CCPlus Home | 2023-06-28 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who |
| 10381934752010 - Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) | 2023-06-09 CardioChek Plus Lipid + eGLU Smart Bundle™ Self-Test test strips are in vitro diagnostic devices used to measure total cholest |
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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