| Primary Device ID | 05055273204438 |
| NIH Device Record Key | d3655da4-41eb-449c-b9aa-66aece9a7521 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lp(a) CAL SET |
| Version Model Number | LP3404 |
| Catalog Number | LP3404 |
| Company DUNS | 227530649 |
| Company Name | RANDOX LABORATORIES LIMITED |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | +442894451070 |
| technical.services@randox.com |
| Special Storage Condition, Specify | Between 0 and 0 *Once reconstituted, the Randox Lp(a) calibrator series is stable for 14 days at +2°C to +8°C in the absence of bacterial contamination. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273204438 [Primary] |
| JIS | Calibrator, Primary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
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