ST AIA-PACK PROG II

GUDID 14560189213392

TOSOH CORPORATION

Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA)
Primary Device ID14560189213392
NIH Device Record Key370592ef-d1fc-44ac-a127-6faa76c843ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameST AIA-PACK PROG II
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189213395 [Unit of Use]
GS114560189213392 [Primary]

FDA Product Code

NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-22
Device Publish Date2019-07-12

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