Neg Control 210543

GUDID 23661562105438

Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique

DIAGAST

Antisera matrix (non-reactive) IVD, control
Primary Device ID23661562105438
NIH Device Record Keyb7aee317-a3fe-4317-b1b2-dd8357b7225d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeg Control
Version Model Number210543
Catalog Number210543
Company DUNS381527001
Company NameDIAGAST
Device Count5
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 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
GS113661562105431 [Unit of Use]
GS123661562105438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSFKit, Quality Control For Blood Banking Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-01

Devices Manufactured by DIAGAST

23661562495584 - Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63)2020-10-28 Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
23661562105261 - Anti-D (RH1) IgM+IgG2020-03-11 Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B10+P3X290+P3X35) - This reagents are designed to
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 Control2018-07-06Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.