ST AIA-PACK PROG II CALIBRATOR SET

GUDID 04560189213418

TOSOH CORPORATION

Progesterone IVD, calibrator
Primary Device ID04560189213418
NIH Device Record Keyb7b76864-dc7d-4c14-9cbe-6824712bb91c
Commercial Distribution StatusIn Commercial Distribution
Brand NameST AIA-PACK PROG II CALIBRATOR 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 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

Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@tosoh.com
Phone615-806-4671
EmailIsabelle.Lang-Zwosta@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

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189213418 [Primary]

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-10
Device Publish Date2026-02-02

On-Brand Devices [ST AIA-PACK PROG II CALIBRATOR SET]

04560189213395N/A
04560189213418N/A

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