| Primary Device ID | 00386100003272 |
| NIH Device Record Key | 3f9947ad-44ac-438e-90a4-3db74874a8fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bi-Level Quality Control Kit |
| Version Model Number | 2814 |
| Catalog Number | 2814 |
| Company DUNS | 112942404 |
| Company Name | MEDICA CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com | |
| Phone | 781-275-4892 |
| technicalsupport@medicacorp.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386100003272 [Primary] |
| CEM | Electrode, Ion Specific, Potassium |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-04 |
| Device Publish Date | 2018-12-04 |
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| 00386100001742 - Chemistry HDL Calibrator Kit | 2019-03-11 HDL Calibrator Kit for use with EasyRA Analyzer |
| 00386100001766 - Chemistry LDL Calibrator | 2019-03-11 LDL Calibrator for use with EasyRA Analyzer |
| 00386100001773 - Chemistry UALB Calibrator Kit | 2019-03-11 Microalbumin Calibrator Kit for use with EasyRA Analyzer |
| 00386100001797 - Chemistry HbA1c Calibrator Kit | 2019-03-11 HbA1c Calibrator Kit for use with EasyRA Analyzer |
| 00386100001803 - CRP Calibrator Kit | 2019-03-11 CRP Calibrator Kit for use with EasyRA Analyzer |
| 00386100001858 - Wash1 Kit | 2019-03-11 Wash1 Kit for use with EasyRA Analyzers |
| 00386100001872 - QC Kit, Level A | 2019-03-11 EasyQC Quality Control Kit - Level for use with EasyRA Analyzer |