Primary Device ID | 30014613337874 |
NIH Device Record Key | 3f8130fb-1950-4fc2-a1d2-528dc15b7a50 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Triage |
Version Model Number | 94401 |
Catalog Number | 94401 |
Company DUNS | 080890141 |
Company Name | QUIDEL CARDIOVASCULAR 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 | 30014613337874 [Primary] |
MLK | Thin layer chroomatography, tricyclic antidepressant drugs |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-12-03 |
Device Publish Date | 2018-11-01 |
30014613338048 | Triage PLGF Test (OUS) |
30014613338031 | Triage NT-proBNP Test (OUS) |
30014613338024 | Triage Troponin I Test (OUS) |
30014613338017 | Triage D-Dimer Test (OUS) |
30014613338000 | Triage D-Dimer Test |
30014613337997 | Triage BNP Test (OUS) |
30014613337980 | Triage BNP Test |
30014613337973 | Triage Cardio2 Panel |
30014613337966 | Triage Cardio3 Panel |
30014613337959 | Triage Profiler SOB Panel (OUS) |
30014613337942 | Triage Cardiac Panel (CK/TnI) |
30014613337935 | Triage Cardiac Panel (TnI) |
30014613337928 | Triage Cardiac Panel (OUS) |
30014613337911 | Triage Cardiac Panel |
30014613337904 | Triage TOX Drug Screen (OUS) |
30014613337898 | Triage TOX Drug Screen (7 Panel) |
30014613337881 | Triage TOX Drug Screen (9 Panel) |
30014613337874 | Triage TOX Drug Screen (10 Panel) |
30014613337867 | Triage TOX Drug Screen |
30014613337720 | Triage BNP Calibrators |
30014613337713 | Triage BNP QC Controls |
30014613337706 | Triage BNP Reagents |
30014613337164 | Triage MeterPro, International |
30014613337157 | Triage MeterPro, North America |
30014613337140 | Triage TOX DS Control 2 |
30014613337133 | Triage TOX DS Control 1 |
30014613337126 | Triage Total 5 Calibration Verification |
30014613337119 | Triage Total 5 Control 2 |
30014613337102 | Triage Total 5 Control 1 |
30014613337096 | Triage Total 3 Control 2 |
30014613337089 | Triage Total 3 Control 1 |
30014613337072 | Triage PLGF Control 2 |
30014613337065 | Triage PLGF Control 1 |
30014613337058 | Triage NT-proBNP Control 2 |
30014613337041 | Triage NT-proBNP Control 1 |
30014613337034 | Triage BNP Calibration Verification |
30014613337027 | Triage BNP Control 2 |
30014613337010 | Triage BNP Control 1 |