Galileo Echo 0087000

GUDID 10888234001584

Immunohaematology/blood bank analyser IVD, automated

Primary Device ID	10888234001584
NIH Device Record Key	456fae1e-e33f-4b7c-8250-eea0a084be81
Commercial Distribution Status	In Commercial Distribution
Brand Name	Galileo Echo
Version Model Number	0087000
Catalog Number	0087000
Company DUNS	061446282
Company Name	IMMUCOR, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.
Special Storage Condition, Specify	Between 0 and 0 *This is an automated laboratory instrument.

Device Issuing Agency	Device ID
GS1	10888234001584 [Primary]

KSZ	System, Test, Automated Blood Grouping And Antibody

Steralize Prior To Use	false
Device Is Sterile	false

10888234001546 - Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum	2022-09-12 Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-
10888234001553 - Capture-R Select	2022-09-12 The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in sol
10888234001560 - Capture-P	2022-09-12 Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is de
10888234001577 - Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum	2022-09-12 Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capt
10888234002291 - Capture LISS	2022-09-12 Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%).
10888234002307 - Capture-R Ready Indicator Red Cells	2022-09-12 Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays
10888234002314 - Capture-P Indicator Red Cells	2022-09-12 Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the dete
10888234001522 - Referencells	2022-08-11 Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.

Mark Image Registration \| Serial	Company Trademark Application Date
GALILEO ECHO 78776081 3277681 Dead/Cancelled	IMMUCOR, INC. 2005-12-19