Primary Device ID | 15099590020347 |
NIH Device Record Key | b871a07c-d3b4-4cd1-be1d-9180e3884933 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AU |
Version Model Number | OSR6270 |
Company DUNS | 008254708 |
Company Name | Beckman Coulter, 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 | 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 | 15099590020347 [Primary] |
CEK | Biuret (Colorimetric), Total Protein |
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 | 2016-09-24 |
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 |