| Primary Device ID | 00850011135761 |
| NIH Device Record Key | f62bb94b-d9db-4935-b5ca-02ddee318b0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VALIDATE |
| Version Model Number | 310ro |
| Company DUNS | 075886031 |
| Company Name | Lgc Clinical Diagnostics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -10 Degrees Celsius |
| 00850011135235 | Validate Anemia is intended for the quantitative determination of Calibration Verification/Linea |
| 00850011135228 | Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearit |
| 00850011135211 | Validate ACTH is intended for the quantitative determination of Calibration Verification/Lineari |
| 00850011135471 | Validate 1300wa is intended for Calibration Verification/Linearity of general chemistries on aut |
| 00850011135464 | Validate 1100wa is intended for Calibration Verification/Linearity of general chemistries on aut |
| 00850011135457 | Validate VIT D Single clinical chemistry analyte IVD, control |
| 00850011135396 | Validate ISX Multiple-type clinical chemistry analyte IVD, control |
| 00850011135495 | aHBs Calibration Verification / Linearity Test kit |
| 00850011135518 | Rubella IgG Calibration Verification / Linearity Test Kit |
| 00850011135525 | Validate UC1 is intended for the determination of Calibration Verification/Linearity on automate |
| 00850011135549 | Toxoplasma IgG Calibration Verification / Linearity Test Kit |
| 00850011135594 | Anti-CCP Calibration Verification / Linearity Test Kit |
| 00850011135624 | VALIDATE OCN Calibration Verification / Linearity Test Kit solutions are intended for in vitro d |
| 00850011135631 | VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro d |
| 00850011135617 | VALIDATE Folate RBC Calibration Verification / Linearity Test Kit solutions are intended for in |
| 00850011135662 | VALIDATE B-CTx Calibration Verification/Linearity Test Kit |
| 00850011135648 | VALIDATE CT Calibration Verification/Linearity Test Kit |
| 00850011135679 | VALIDATE Fertility 4 Calibration Verification/Linearity Test Kit |
| 00850011135723 | Validate THY Calibration Verification / Linearity Test Kit solutions are intended for in vitro d |
| 00850011135730 | Validate LCMS VIT D Test Kit |
| 00850011135761 | VALIDATE MTX Calibration Verification / Linearity Test Kit |
| 00850011135808 | Growth Hormone 2 Calibration Verification / Linearity Test Kit |
| 00850011135563 | Validate LCMS Steroids Test Kit |
