IH-Titration Rack 813550100

GUDID 07611969964505

IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500.

Bio-Rad Medical Diagnostics GmbH

Assay container IVD, single-use
Primary Device ID07611969964505
NIH Device Record Keydf63cbb2-defa-4706-8a87-e048669d2ec6
Commercial Distribution StatusIn Commercial Distribution
Brand NameIH-Titration Rack
Version Model Number813550100
Catalog Number813550100
Company DUNS312576506
Company NameBio-Rad Medical Diagnostics GmbH
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 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611969964505 [Primary]

FDA Product Code

KSGMedia, Potentiating For In Vitro Diagnostic Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-17
Device Publish Date2022-03-09

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 Rack2022-03-17IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500.
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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