CL AIA-PACK SAMPLE DILUTING REAGENT A

GUDID 24562185395390

TOSOH CORPORATION

Buffered sample diluent IVD
Primary Device ID24562185395390
NIH Device Record Keyca064403-5456-4d0e-aa62-f9d00d20d3f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCL AIA-PACK SAMPLE DILUTING REAGENT A
Version Model NumberN/A
Company DUNS690571724
Company NameTOSOH CORPORATION
Device Count3
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

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
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104562185395396 [Unit of Use]
GS114562185395393 [Primary]
GS124562185395390 [Package]
Contains: 14562185395393
Package: [20 Units]
In Commercial Distribution

FDA Product Code

GIFDiluent, Blood Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-09
Device Publish Date2025-09-01

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24562185395390 - CL AIA-PACK SAMPLE DILUTING REAGENT A2025-09-09
24562185395444 - CL AIA-PACK T3 TEST CUP2025-09-09
24562185395451 - CL AIA-PACK T3 ADJUSTER SET2025-09-09
24562185399657 - CL AIA-PACK SAMPLE DILUTING REAGENT D2025-09-09
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