Capture-R Ready-Screen (I and II) 0006440

GUDID 10888234000648

Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or au

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 ID10888234000648
NIH Device Record Keyb3e21ab5-6e40-44eb-a7e1-d02622454659
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapture-R Ready-Screen (I and II)
Version Model Number0006440
Catalog Number0006440
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 Latextrue
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
GS110888234000648 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-06-04

On-Brand Devices [Capture-R Ready-Screen (I and II)]

10888234001867Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibod
10888234001201Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibod
10888234000648Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibod
10888234000631Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibod

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