ST AIA-PACK PAP

GUDID 14560189210612

TOSOH CORPORATION

Prostatic acid phosphatase (PAP) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID14560189210612
NIH Device Record Key0d7685f6-5753-48f6-a1bc-0f09e6ddc994
Commercial Distribution StatusIn Commercial Distribution
Brand NameST AIA-PACK PAP
Version Model NumberN/A
Company DUNS690571724
Company NameTOSOH CORPORATION
Device Count5
DM Exemptfalse
Pre-market Exempttrue
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189210615 [Unit of Use]
GS114560189210612 [Primary]

FDA Product Code

JFHAcid Phosphatase (Prostatic), Tartrate Inhibited

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

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