FDA UDI
In Commercial Distribution
🇺🇸 United States
HbA1c Quality Control Kit Level 1
DI: 00386100001896
·
Model: 10795
·
MEDICA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HbA1c Quality Control Kit Level 1
- Primary DI
- 00386100001896
- Version / Model
- 10795
- Catalog Number
- 10795
- Company Name
- MEDICA CORPORATION
- Labeler DUNS
- 112942404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-14
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 942d9af0-991b-403f-bc59-26487b3a85a4
Device Description
HbA1c Quality Control Kit Level 1 for use with EasyRA Analyzer
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 52860 | Multiple blood gas/haemoximetry/electrolyte analyte IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00386100001896 | GS1 |
Customer Contacts
- Phone
- 781-275-4892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120497 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius