Primary Device ID | 23661562105254 |
NIH Device Record Key | 30d6453c-3942-44ae-99cd-a83e11da0b5d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anti-D (RH1) IgM |
Version Model Number | 210525 |
Catalog Number | 210525 |
Company DUNS | 381527001 |
Company Name | DIAGAST |
Device Count | 5 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com | |
Phone | (800) 452-6877 |
service.americas@grifols.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 13661562105257 [Unit of Use] |
GS1 | 23661562105254 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-06-01 |
Device Publish Date | 2018-05-01 |
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+IgG | 2020-03-11 Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B10+P3X290+P3X35) - This reagents are designed to |
23661562105445 - LISS | 2018-09-12 Low-ionic-strength phosphate buffered saline solution ready for use to prepare human red blood cell suspensions for immunohemato |
23661562105438 - Neg Control | 2018-07-06 Negative control reagent for Anti-D Monoclonal Blood Grouping Reagents (210524-210525-210526) for manual tube technique |
23661562173178 - Beckman Coulter® PK® Systems Control | 2018-07-06 Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System |
23661562173307 - Beckman Coulter® PK® Systems Bromelin | 2018-07-06 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 |