| Primary Device ID | 00812137012142 |
| NIH Device Record Key | fd2eb551-ab08-495d-b884-404d0e6b9184 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CRP Calibrator Set |
| Version Model Number | 5 x 2mL |
| Catalog Number | 502-154 |
| Company DUNS | 048144997 |
| Company Name | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| Device Count | 5 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| 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 |
| Phone | 8004533328 |
| quality@cdsolinc.com | |
| Phone | 8004533328 |
| quality@cdsolinc.com | |
| Phone | 8004533328 |
| quality@cdsolinc.com | |
| Phone | 8004533328 |
| quality@cdsolinc.com | |
| Phone | 8004533328 |
| quality@cdsolinc.com | |
| Phone | 8004533328 |
| quality@cdsolinc.com | |
| Phone | 8004533328 |
| quality@cdsolinc.com | |
| Phone | 8004533328 |
| quality@cdsolinc.com | |
| Phone | 8004533328 |
| quality@cdsolinc.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 | 00812137012142 [Primary] |
| GS1 | 00812137012432 [Unit of Use] |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-12 |
| 00001812701208 - Triglycerides Reagent | 2020-03-31 For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in |
| 00812137011848 - Albumin Reagent | 2020-03-31 For the quantitative determination of Albumin in serum. |
| 00812137010254 - CDS-LTX CONTROL | 2018-07-06 CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S in |
| 00812137010261 - CDS-LTX PRIMER | 2018-07-06 CDS-LTX Primer is used to prepare the tubing and instrument components on the COULTER HmX/MAXM, STKS and GEN-S instruments pr |
| 00812137011947 - Carbon Dioxide Reagent | 2018-06-11 For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. |
| 00812137011916 - Urea Nitrogen Reagent Set | 2018-04-17 For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen |
| 00081213701184 - Albumin Reagent | 2018-03-29 For the quantitative determination of Albumin in serum. |
| 00812137010216 - Boule Con-Diff Tri-Level | 2018-03-29 For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff T |