FDA UDI
In Commercial Distribution
🇺🇸 United States
AgaMatrix
DI: 10385542013013
·
Model: 8000-02013
·
AgaMatrix, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- AgaMatrix
- Primary DI
- 10385542013013
- Version / Model
- 8000-02013
- Company Name
- AgaMatrix, Inc.
- Labeler DUNS
- 156756129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-04
- Public Version
- 5
- Public Version Date
- 2025-09-23
- Public Version Status
- Update
- Public Device Record Key
- 94b8c94f-2502-4514-bc15-8949dc0d78cd
Device Description
Control Solution, AgaMatrix, High
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41819 | Glucose IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20385542011016 | GS1 | Shipper | 48 | In Commercial Distribution | |
| Package | 00385542011012 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 10385542013013 | GS1 |
Customer Contacts
- Phone
- 1-866-906-4197
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit