Auto-Prep Unit for AIA-CL1200

GUDID 04562185400601

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 ID04562185400601
NIH Device Record Keyc166fd7e-5443-4674-9179-6df4f62c8ad4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuto-Prep Unit for AIA-CL1200
Version Model NumberN/A
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 indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and store indoor

Device Identifiers

Device Issuing AgencyDevice ID
GS104562185400601 [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

Devices Manufactured by TOSOH CORPORATION

14560189212234 - AIA-PACK AFP Calibration Verification Test Set2024-04-01
14560189212241 - AIA-PACK CEA Calibration Verification Test Set2024-04-01
14560189212258 - AIA-PACK FER Calibration Verification Test Set2024-04-01
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.