Primary Device ID | 07611969964505 |
NIH Device Record Key | df63cbb2-defa-4706-8a87-e048669d2ec6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IH-Titration Rack |
Version Model Number | 813550100 |
Catalog Number | 813550100 |
Company DUNS | 312576506 |
Company Name | Bio-Rad Medical Diagnostics GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07611969964505 [Primary] |
KSG | Media, Potentiating For In Vitro Diagnostic Use |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-17 |
Device Publish Date | 2022-03-09 |
03610520569870 - IH-Com | 2022-03-22 IH-Com Kit Fullversion US; Software Version: 04.0.27. |
03610522055685 - IH-Card ABO Neutral | 2022-03-17 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 Rack | 2022-03-17IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500. |
07611969964505 - IH-Titration Rack | 2022-03-17 IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500. |
07611969952205 - IH-Titration Solution | 2022-03-11 IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with a |
07611969233786 - IH-500 | 2022-01-31 IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of hu |
03610522123919 - IH-Com V5.2 | 2021-02-26 IH-Com V5.2, Software Version 5.2 |
03610522165049 - Wash Solution A Concentrate | 2020-02-13 Wash Solution for use with the IH-500 |
07611969951369 - Alsevers Solution | 2019-11-27 Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods |