Capture LISS 0006418

GUDID 10888234002147

Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies

IMMUCOR, INC.

Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Primary Device ID10888234002147
NIH Device Record Keya252ad65-3d92-4c00-ba03-463423f2f48a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapture LISS
Version Model Number0006418
Catalog Number0006418
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 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234002147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSSSupplies, Blood-Bank

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-12
Device Publish Date2016-04-14

On-Brand Devices [Capture LISS]

10888234002147Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Cap
10888234001218Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Cap
10888234000587Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Cap
10888234000570Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Cap
10888234002291Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the p
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