Capture-R Ready-Screen (3) 0066816

GUDID 10888234002369

Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase

IMMUCOR, INC.

Solid phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD Solid-phase red blood cell adherence antibody/antigen IVD
Primary Device ID10888234002369
NIH Device Record Key2952ce7b-8d94-42bf-9401-678db5f6705a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapture-R Ready-Screen (3)
Version Model Number0066816
Catalog Number0066816
Company DUNS061446282
Company NameIMMUCOR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com
Phone1-855-466-8267
Emailtech_support@immucor.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234002369 [Primary]

FDA Product Code

KSZSystem, Test, Automated Blood Grouping And Antibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-15
Device Publish Date2018-09-12

On-Brand Devices [Capture-R Ready-Screen (3)]

10888234002369Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
10888234001935Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
10888234001478Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
10888234001461Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
10888234001454Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
10888234001423Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce
10888234001416Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood ce

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