AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360

GUDID 04560189282896

TOSOH CORPORATION

Enzyme immunoassay (EIA) analyser IVD
Primary Device ID04560189282896
NIH Device Record Keya9eeae2d-b5e0-40d1-b59e-0f63824de4c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360
Version Model NumberAIA-360
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
GS104560189282896 [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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14560189212272 - AIA-PACK PAP CALIBRATION VERIFICATION TEST SET2024-04-01
14560189212296 - AIA-PACK bHCG Calibration Verification Test Set2024-04-01
14560189212807 - AIA-PACK Homocysteine Control Set2024-04-01
14560189211190 - AIA-PACK FT3 Calibrator Set2024-02-14
14560189211213 - AIA-PACK TT3 SAMPLE DILUTING SOLUTION2024-02-14

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