ABDR SSPtray 826230

GUDID 07611969953301

for 24 determinations of HLA-ABDR alleles; For In Vitro Diagnostic Use

Bio-Rad Medical Diagnostics GmbH

HLA class I & II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
Primary Device ID07611969953301
NIH Device Record Key7a03f83d-1b63-428f-ac99-a396ab872673
Commercial Distribution StatusIn Commercial Distribution
Brand NameABDR SSPtray
Version Model Number826230
Catalog Number826230
Company DUNS312576506
Company NameBio-Rad Medical Diagnostics GmbH
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.com
Phone800-224-6723
Emailtechsupport.bmd@bio-rad.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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611969953301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZITest,Qualitative,For Hla,Non-Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-01

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03610522165049 - Wash Solution A Concentrate2020-02-13 Wash Solution for use with the IH-500
07611969951369 - Alsevers Solution2019-11-27 Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods

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