FDA UDI
In Commercial Distribution
🇺🇸 United States
A1CNow®+ Multi-UseTest System (20 count)
DI: 00381933021011
·
Model: 3021
·
POLYMER TECHNOLOGY SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- A1CNow®+ Multi-UseTest System (20 count)
- Primary DI
- 00381933021011
- Version / Model
- 3021
- Catalog Number
- 3021
- Company Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Labeler DUNS
- 835772872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-08-05
- Public Version
- 5
- Public Version Date
- 2022-04-14
- Public Version Status
- Update
- Public Device Record Key
- f7e54125-fc90-4ee3-8045-5e2fe2ce1056
Device Description
The A1CNow®+ Multi-Use 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)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| 62206 | Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care | A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. 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 |
|---|---|---|---|---|---|---|
| Primary | 00381933021011 | GS1 | ||||
| Unit of Use | 10381933021018 | GS1 |
Customer Contacts
- Phone
- +1(888)877-5610
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090413 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- If refrigerated, ensure components are at room temperature prior to use.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Product may be stored for a total of four months at room temperature (18-25 degrees C) anytime before the expiration date.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 46 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius