Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200

GUDID 04562185400588

TOSOH CORPORATION

Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD
Primary Device ID04562185400588
NIH Device Record Key5394ac89-6ae2-464d-b68a-0cfe50a891c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200
Version Model NumberAIA-CL1200 ST
Company DUNS690571724
Company NameTOSOH CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com
Phone650-615-8134
Emaildave.wurtz@tosoh.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoors

Device Identifiers

Device Issuing AgencyDevice ID
GS104562185400588 [Primary]

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

On-Brand Devices [Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200]

04562185400595AIA-CL1200 LA
04562185400588AIA-CL1200 ST

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.