FDA UDI
In Commercial Distribution
🇺🇸 United States
TRUE+ A1CNow Self Check
DI: 00021292015022
·
Model: 3075
·
POLYMER TECHNOLOGY SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- TRUE+ A1CNow Self Check
- Primary DI
- 00021292015022
- Version / Model
- 3075
- Catalog Number
- 3075
- Company Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Labeler DUNS
- 835772872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-07-30
- Public Version
- 2
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- aeb1a1de-a2dd-49e4-ae70-56f3a5c07d24
Device Description
The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62205 | Glycated haemoglobin (HbA1c) monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10021292015029 | GS1 | case | 24 | In Commercial Distribution | |
| Primary | 00021292015022 | GS1 | ||||
| Unit of Use | 20021292015026 | GS1 |
Customer Contacts
- Phone
- +1(877)870-5610
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090413 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 64 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight Keep dry