FDA UDI
In Commercial Distribution
🇺🇸 United States
A1CNow+ Controls™ Levels 1+2
DI: 00381930737014
·
Model: 737
·
POLYMER TECHNOLOGY SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- A1CNow+ Controls™ Levels 1+2
- Primary DI
- 00381930737014
- Version / Model
- 737
- Catalog Number
- 737
- Company Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Labeler DUNS
- 835772872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-15
- Public Version
- 3
- Public Version Date
- 2023-01-23
- Public Version Status
- Update
- Public Device Record Key
- bc66061f-8e74-4fee-80d4-453345fe1193
Device Description
The A1CNow+ Controls™ are supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. The control consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the A1CNow system. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44435 | Glycated haemoglobin (HbA1c) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00381930737014 | GS1 |
Customer Contacts
- Phone
- +1(888)877-5610
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103744 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
- Type
- Special Storage Condition, Specify
- Special Conditions
- The control may be received thawed and should be re-frozen upon arrival.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 14 Degrees Fahrenheit