AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST

GUDID 04560189284616

TOSOH CORPORATION

Enzyme immunoassay (EIA) analyser IVD
Primary Device ID04560189284616
NIH Device Record Key0c7dc128-7d19-4bd9-b927-dd1463d4bd10
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST
Version Model NumberAIA-2000 ST
Company DUNS690571724
Company NameTOSOH CORPORATION
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

Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@tosoh.com
Phone650-636-8228
EmailKen.Hood@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

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189284616 [Primary]

FDA Product Code

KHOFluorometer, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-09-16
Device Publish Date2019-09-02

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