Capture-R Ready-Screen (I and II) 0006439

GUDID 10888234000631

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
Primary Device ID10888234000631
NIH Device Record Key43bbfb83-6d4b-4e29-b451-5c3421a18bfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapture-R Ready-Screen (I and II)
Version Model Number0006439
Catalog Number0006439
Company DUNS061446282
Company NameIMMUCOR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS110888234000631 [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 Date2016-04-14

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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