AIA-PACK PA CALIBRATION VERIFICATION TEST SET

GUDID 04560189211971

TOSOH CORPORATION

Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control
Primary Device ID04560189211971
NIH Device Record Keyb3f6c75c-7a4c-4937-ba3f-1165f887bbe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIA-PACK PA CALIBRATION VERIFICATION TEST SET
Version Model Numbern/a
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 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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189211971 [Primary]
GS114560189211978 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Product Code

JITCalibrator, Secondary
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2014-09-24

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