AFFIRMAGEN 719210
GUDID 10758750003907
Affirmagen® (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 ID | 10758750003907 |
| NIH Device Record Key | c233e7b7-d067-4912-880d-484b457bd0a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AFFIRMAGEN |
| Version Model Number | 719210 |
| Catalog Number | 719210 |
| Company DUNS | 068715424 |
| Company Name | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10758750003907 [Primary] |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-06-08 |
| Device Publish Date | 2014-10-22 |
On-Brand Devices [AFFIRMAGEN]
| 10758750003914 | 0.8% Affirmagen® 3 (Pooled Cells) |
| 10758750003907 | Affirmagen® (Pooled Cells) |
| 10758750003877 | 0.8% Affirmagen® (Pooled Cells) |
Trademark Results [AFFIRMAGEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFIRMAGEN 72205195 0793551 Live/Registered |
ORTHO PHARMACEUTICAL CORPORATION 1964-10-30 |
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