Biotestcell® 1 & 2 816014100

GUDID 07611969952380

Reagent Red Blood Cells; 3.0 - 3.4%; for use in detection of unexpected antibodies with TANGO instruments and by tube test; 2x10ml

Bio-Rad Medical Diagnostics GmbH

Antibody screening reagent red blood cell IVD, kit, agglutination
Primary Device ID07611969952380
NIH Device Record Key5c8964bf-40a8-4422-8078-fb6592b5aa7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotestcell® 1 & 2
Version Model Number816014100
Catalog Number816014100
Company DUNS312576506
Company NameBio-Rad Medical Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107611969952380 [Primary]

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 Date2014-09-17

Devices Manufactured by Bio-Rad Medical Diagnostics GmbH

03610520569870 - IH-Com2022-03-22 IH-Com Kit Fullversion US; Software Version: 04.0.27.
03610522055685 - IH-Card ABO Neutral2022-03-17 The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
07611969964505 - IH-Titration Rack2022-03-17 IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500.
07611969952205 - IH-Titration Solution2022-03-11 IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with a
07611969233786 - IH-5002022-01-31 IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of hu
03610522123919 - IH-Com V5.22021-02-26 IH-Com V5.2, Software Version 5.2
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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