AFFIRMAGEN 719211

GUDID 10758750003914

0.8% Affirmagen® 3 (Pooled Cells)

ORTHO-CLINICAL DIAGNOSTICS, INC.

Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
Primary Device ID10758750003914
NIH Device Record Key6e2a2362-382e-47ec-899b-3e0ef3923ed7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFFIRMAGEN
Version Model Number719211
Catalog Number719211
Company DUNS068715424
Company NameORTHO-CLINICAL DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

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
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
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
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
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
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110758750003914 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-06-08
Device Publish Date2014-10-22

On-Brand Devices [AFFIRMAGEN]

107587500039140.8% Affirmagen® 3 (Pooled Cells)
10758750003907Affirmagen® (Pooled Cells)
107587500038770.8% Affirmagen® (Pooled Cells)

Trademark Results [AFFIRMAGEN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFIRMAGEN
AFFIRMAGEN
72205195 0793551 Live/Registered
ORTHO PHARMACEUTICAL CORPORATION
1964-10-30

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