DxSelect™ Amber Sample Diluent

GUDID 10816101022240

DIASORIN MOLECULAR LLC

Immunohistochemistry antibody diluent IVD
Primary Device ID10816101022240
NIH Device Record Keycd231dfb-d8ef-491b-af12-3073a543f989
Commercial Distribution Discontinuation2024-07-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDxSelect™ Amber Sample Diluent
Version Model NumberEL1708
Company DUNS080271715
Company NameDIASORIN MOLECULAR LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.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

Device Identifiers

Device Issuing AgencyDevice ID
GS110816101022240 [Primary]

FDA Product Code

MIZEnzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-07-09
Device Publish Date2016-09-22

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