OPTIGEN® AP 3600™ Automated Instrument 95413

GUDID 00813382010204

Automated In Vitro Allergy Diagnostic System

HITACHI CHEMICAL DIAGNOSTICS, INC.

Chemiluminescent immunoassay analyser IVD, automated
Primary Device ID00813382010204
NIH Device Record Keyd60daf39-4097-4f5f-80aa-06c5811136f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTIGEN® AP 3600™ Automated Instrument
Version Model Number95413
Catalog Number95413
Company DUNS102113867
Company NameHITACHI CHEMICAL DIAGNOSTICS, INC.
Device Count1
DM Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com
Phone+1(650)961-5501
Emailinfo@hcdiagnostics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813382010204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHBSystem, test, radioallergosorbent (rast) immunological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-30
Device Publish Date2019-05-22

Devices Manufactured by HITACHI CHEMICAL DIAGNOSTICS, INC.

00813382010204 - OPTIGEN® AP 3600™ Automated Instrument2019-05-30Automated In Vitro Allergy Diagnostic System
00813382010204 - OPTIGEN® AP 3600™ Automated Instrument2019-05-30 Automated In Vitro Allergy Diagnostic System
00813382010426 - OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND)2019-05-30 KIT, OPTIGEN US Inhalant 36 (100 ND)
00813382010433 - OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND)2019-05-30 KIT, OPTIGEN US Food 25 (100 ND)
00813382010440 - OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND)2019-05-30 KIT, OPTIGEN US Food 25
00813382010006 - OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel2018-07-06 KIT, OPTIGEN Universal Panel 20
00813382010075 - OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel2018-07-06 KIT, OPTIGEN Universal Panel 20
00813382010082 - OPTIGEN® Positive Control Reagent2018-07-06 OPTIGEN Positive Control
00813382010099 - OPTIGEN® Negative Control Reagent2018-07-06 OPTIGEN Negative Control

Trademark Results [OPTIGEN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTIGEN
OPTIGEN
90766956 not registered Live/Pending
Musculoskeletal Transplant Foundation
2021-06-10
OPTIGEN
OPTIGEN
90611908 not registered Live/Pending
Hitachi Chemical Diagnostics, Inc.
2021-03-30
OPTIGEN
OPTIGEN
88463902 not registered Live/Pending
Lincare Licensing, Inc.
2019-06-07
OPTIGEN
OPTIGEN
86263132 4621270 Live/Registered
Alltech, Inc.
2014-04-25
OPTIGEN
OPTIGEN
85714376 4417074 Live/Registered
Lincare Licensing Inc.
2012-08-28
OPTIGEN
OPTIGEN
78344154 not registered Dead/Abandoned
Tangent Group
2003-12-22
OPTIGEN
OPTIGEN
78340427 3197258 Live/Registered
Hitachi Chemical Diagnostics, Inc.
2003-12-12
OPTIGEN
OPTIGEN
77543525 3790859 Live/Registered
Winkle Industries, Inc.
2008-08-11
OPTIGEN
OPTIGEN
76683869 not registered Dead/Abandoned
Farsaie, Ali
2007-11-09
OPTIGEN
OPTIGEN
76435763 not registered Dead/Abandoned
Spatial Integrated Systems, Inc.
2002-07-30
OPTIGEN
OPTIGEN
75742067 2502690 Live/Registered
ALLTECH, INC.
1999-07-01
OPTIGEN
OPTIGEN
75559458 not registered Dead/Abandoned
Millipore Corporation
1998-09-25
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.