Capture-R Select 0006446

GUDID 10888234000655

Capture-R Select solid phase system provides modified micro-wells for the immobilization of human erythrocytes for use in solid phase assays for the d

IMMUCOR, INC.

Microplate IVD
Primary Device ID10888234000655
NIH Device Record Keyf9cfad0c-c88e-47d0-8dfb-f610b306e609
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapture-R Select
Version Model Number0006446
Catalog Number0006446
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 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234000655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSZSystem, Test, Automated Blood Grouping And Antibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-15

On-Brand Devices [Capture-R Select]

10888234000655Capture-R Select solid phase system provides modified micro-wells for the immobilization of huma
10888234001553The Capture-R Select Solid Phase System provides modified microwells for the immobilization of h

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