ST AIA-PACK ACTH

GUDID 14560189212517

TOSOH CORPORATION

Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID14560189212517
NIH Device Record Keyfad93f5a-dbc6-49ad-9361-4be476b10f9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameST AIA-PACK ACTH
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189212510 [Unit of Use]
GS114560189212517 [Primary]

FDA Product Code

CKGRadioimmunoassay, Acth

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.