SPOTCHEM™ EZ Analyzer

GUDID 00015482183103

Dry Chemistry Analyzer IVD, semi-automated

ARKRAY USA, INC.

Magnesium (Mg2+) IVD, kit, spectrophotometry
Primary Device ID00015482183103
NIH Device Record Keyc69686ec-f140-4534-ac8c-167e43332659
Commercial Distribution Discontinuation2024-05-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSPOTCHEM™ EZ Analyzer
Version Model Number18310
Company DUNS008171162
Company NameARKRAY USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx
Phone+1(999)999-9999
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS100015482183103 [Primary]

FDA Product Code

CGAGLUCOSE OXIDASE, GLUCOSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-05-31
Device Publish Date2016-09-23

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00015482181574 - AUTION EYE™ Control Solution H/L2024-12-10 AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the
00015482181598 - AUTION EYE™ Calibrator Focus/Calibrator2024-12-10 AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510.
00015482188627 - AUTION EYE™ AI-4510 Analyzer2024-12-10 The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use.
14987486005299 - Concentrated Washing Solution 32024-12-10 A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated ins
00015482183103 - SPOTCHEM™ EZ Analyzer2024-05-31Dry Chemistry Analyzer IVD, semi-automated
00015482183103 - SPOTCHEM™ EZ Analyzer2024-05-31 Dry Chemistry Analyzer IVD, semi-automated

Trademark Results [SPOTCHEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPOTCHEM
SPOTCHEM
79212401 5455851 Live/Registered
ARKRAY, Inc.
2017-03-15
SPOTCHEM
SPOTCHEM
78239536 2910438 Live/Registered
ARKRAY, INC.
2003-04-18

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