Primary Device ID | 00015482183103 |
NIH Device Record Key | c69686ec-f140-4534-ac8c-167e43332659 |
Commercial Distribution Discontinuation | 2024-05-30 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | SPOTCHEM™ EZ Analyzer |
Version Model Number | 18310 |
Company DUNS | 008171162 |
Company Name | ARKRAY USA, 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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx | |
Phone | +1(999)999-9999 |
xxx@xxx.xxx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00015482183103 [Primary] |
CGA | GLUCOSE OXIDASE, GLUCOSE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2024-05-31 |
Device Publish Date | 2016-09-23 |
00015482183103 - SPOTCHEM™ EZ Analyzer | 2024-05-31Dry Chemistry Analyzer IVD, semi-automated |
00015482183103 - SPOTCHEM™ EZ Analyzer | 2024-05-31 Dry Chemistry Analyzer IVD, semi-automated |
00015482771010 - SPOTCHEM™ II Glucose | 2024-05-31 Strip description for the invitro quantitative determination of glucose in human plasma from whole blood samples |
00015482771027 - SPOTCHEM™ II Uric Acid | 2024-05-31 Strip description for the invitro quantitative determination of uric acid concentration in human plasma from whole blood samples |
00015482771034 - SPOTCHEM™ II Total Cholesterol | 2024-05-31 Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples |
00015482771041 - SPOTCHEM™ II Triglycerides | 2024-05-31 Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples |
00015482771058 - SPOTCHEM™ II BUN | 2024-05-31 Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples |
00015482771065 - SPOTCHEM™ II Total Bilirubin | 2024-05-31 Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood s |
00015482771072 - SPOTCHEM™ II Calcium | 2024-05-31 Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPOTCHEM 79212401 5455851 Live/Registered |
ARKRAY, Inc. 2017-03-15 |
SPOTCHEM 78239536 2910438 Live/Registered |
ARKRAY, INC. 2003-04-18 |