Erytype® S ABO Donor 806130100

GUDID 07611969951178

ABO/Rh(D) multiple blood grouping IVD, kit, agglutination

Primary Device ID	07611969951178
NIH Device Record Key	f820cf35-80e4-4335-bd8b-bc0752b466cf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Erytype® S ABO Donor
Version Model Number	806130100
Catalog Number	806130100
Company DUNS	312576506
Company Name	Bio-Rad Medical Diagnostics GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Device Kit	true
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	true
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
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	07611969951178 [Primary]

Steralize Prior To Use	false
Device Is Sterile	false

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	2022-03-17 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

Mark Image Registration \| Serial	Company Trademark Application Date
ERYTYPE 78170994 2833279 Live/Registered	BIO-RAD MEDICAL DIAGNOSTICS GMBH 2002-10-04
ERYTYPE 73633149 not registered Dead/Abandoned	BIOTEST-SERUM-INSTITUT GMBH 1986-12-01