| Primary Device ID | 15099590010614 |
| NIH Device Record Key | d1d1935e-e0c2-49ef-a14c-280408de2625 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AU |
| Version Model Number | OSR6164 |
| Catalog Number | OSR6164 |
| Company DUNS | 008254708 |
| Company Name | Beckman Coulter, Inc. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15099590010614 [Primary] |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control |
| 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 | 2017-02-17 |
| 15099590670108 | Urine CSF Albumin |
| 15099590635565 | URINE CREATININE CALIBRATOR |
| 15099590635534 | URINE CHEMISTRY CALIBRATOR |
| 15099590140076 | ISE Buffer Solution |
| 15099590140069 | ISE Mid Standard Solution |
| 15099590140052 | ISE Reference Solution |
| 15099590140045 | ISE Low Serum Standard |
| 15099590140038 | ISE High Serum Standard |
| 15099590140021 | ISE Low/High Urine Standard |
| 15099590140014 | ISE Internal Reference Solution |
| 15099590140007 | ISE Na+/K+ Selectivity Check Solution |
| 15099590080884 | D-Dimer Calibrator |
| 15099590080860 | Wash Solution |
| 15099590080839 | Prealbumin Calibrator |
| 15099590080785 | Serum Protein Multi-Calibrator 2 |
| 15099590080778 | APO A1 & B Calibrator |
| 15099590080761 | Serum Protein Multi-Calibrator 1 |
| 15099590070588 | D-Dimer Control |
| 15099590070571 | RF Latex Calibrator |
| 15099590070564 | CRP Latex Calibrator Highly Sensitive (HS) Set |
| 15099590070557 | CRP Latex Calibrator Normal (N) Set |
| 15099590070519 | LDL Cholesterol Calibrator |
| 15099590070502 | HDL Cholesterol Calibrator |
| 15099590060213 | Urea Stat/Urea Nitrogen Stat |
| 15099590060206 | Bicarbonate |
| 15099590060183 | Calcium Arsenazo |
| 15099590060176 | Total Bilirubin |
| 15099590060169 | Direct Bilirubin |
| 15099590060152 | Uric Acid |
| 15099590060145 | Triglyceride |
| 15099590060114 | Urea/Urea Nitrogen |
| 15099590060091 | Total Protein |
| 15099590060084 | Glucose |
| 15099590060077 | Creatinine |
| 15099590060060 | Cholesterol |
| 15099590060039 | AST |
| 15099590060022 | ALT |
| 15099590060015 | ALP |
| 15099590060008 | Albumin |
| 15099590050405 | Urea Stat/Urea Nitrogen Stat |
| 15099590050085 | AST |
| 15099590020422 | Urine CSF Albumin |
| 15099590020408 | LIH |
| 15099590020385 | Uric Acid |
| 15099590020361 | LDL-Cholesterol |
| 15099590020354 | HDL-Cholesterol |
| 15099590020347 | Urinary/CSF Protein |
| 15099590020279 | Iron |
| 15099590020262 | CK (NAC) |
| 15099590020187 | Bicarbonate |