ST AIA-PACK Testosterone CALIBRATOR SET

GUDID 04560189211339

TOSOH CORPORATION

Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator Total testosterone IVD, calibrator
Primary Device ID04560189211339
NIH Device Record Key08d2fe86-a24d-45d4-a42d-d559f579b316
Commercial Distribution StatusIn Commercial Distribution
Brand NameST AIA-PACK Testosterone CALIBRATOR SET
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@tosoh.com
Phone614-317-1909
EmailLevent.durukan@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

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189211339 [Primary]

FDA Product Code

CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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.