Anti-Lea (LE1) 210541

GUDID 23661562105414

Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) (13643B9) - This reagent is designed to determine the presence of the blood group antigen Lea (LE

DIAGAST

Anti-Le^a red blood cell grouping IVD, antibody
Primary Device ID23661562105414
NIH Device Record Keyaf67487a-ea88-4e79-9b63-c41a15bbf7a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Lea (LE1)
Version Model Number210541
Catalog Number210541
Company DUNS381527001
Company NameDIAGAST
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com
Phone(800) 452-6877
Emailservice.americas@grifols.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS123661562105414 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-01
Device Publish Date2018-05-01

Devices Manufactured by DIAGAST

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23661562105445 - LISS2018-09-12 Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohemato
23661562105438 - Neg Control2018-07-06 Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
23661562173178 - Beckman Coulter® PK® Systems Control2018-07-06 Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System
23661562173307 - Beckman Coulter® PK® Systems Bromelin2018-07-06 Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System
23661562105209 - Anti-A (AB01)2018-06-01 Blood Grouping Reagent, Anti-A (Murine Monoclonal) (9113D10) - This reagent is designed to determine the presence of ABO system
23661562105216 - Anti-B (AB02)2018-06-01 Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system b

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