| Primary Device ID | B3959900300 |
| NIH Device Record Key | 87ac9701-4d6e-4d6b-95dd-5880b0cc7a59 |
| Commercial Distribution Discontinuation | 2019-09-19 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Vantera Clinical Analyzer |
| Version Model Number | 9900300 |
| Catalog Number | 9900300 |
| Company DUNS | 012822243 |
| Company Name | Labcorp of America |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 919-256-1157 |
| bakers9@labcorp.com | |
| Phone | 919-256-1157 |
| bakers9@labcorp.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B3959900300 [Primary] |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-25 |
| Device Publish Date | 2016-11-11 |
| B3959900300 - Vantera Clinical Analyzer | 2019-09-25Clinical Analyzer |
| B3959900300 - Vantera Clinical Analyzer | 2019-09-25 Clinical Analyzer |
| B3959910030 - NMR WASH Solution | 2019-09-25 WASH Solution used for the Vantera Clinical Analyzer |
| B3959920030 - NMR Diluent 1 | 2019-09-25 Sample Diluent 1 used for the Vantera Clinical Analyzer. |
| B3959930030 - NMR Reference Standard | 2019-09-25 NMR Reference Standard used for the Vantera Clinical Analyzer. |