BIOCLONE 716000
GUDID 10758750003457
Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination| Primary Device ID | 10758750003457 |
| NIH Device Record Key | 57f83641-1035-49f3-a215-eb9b61d7060e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOCLONE |
| Version Model Number | 716000 |
| Catalog Number | 716000 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10758750003457 [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 [BIOCLONE]
| 10758750007455 | Anti-D BIOCLONE 3x10ml |
| 10758750007448 | Anti-B BIOCLONE 3x10ml |
| 10758750007431 | Anti-A BIOCLONE 3x10ml |
| 10758750004157 | Anti-Jkb (Monoclonal) BioClone |
| 10758750004140 | Anti-Jka (Monoclonal) BioClone |
| 10758750003662 | ANTI-D BIOCLONE 15X10ML |
| 10758750003624 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML Green |
| 10758750003600 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML Green |
| 10758750003570 | C3B C3D BIOCLONE 1X3ML |
| 10758750003563 | ANTI-C3D BIOCLONE 1X3ML |
| 10758750003471 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML |
| 10758750003457 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML |
| 10758750003389 | ANTI-LEA (LE1) (MURINE MONOCLONAL) BIOCLONE 2.0 |
| 10758750003297 | ANTI-SMALL E (ANTI-RH5) (MONOCLONAL) BIOCLONE 1X5ML |
| 10758750003266 | ANTI-SMALL C (ANTI-RH4) (MONOCLONAL) BIOCLONE 1X5ML |
| 10758750003259 | ANTI-E (ANTI-RH3) (MONOCLONAL) BIOCLONE 1X5ML |
| 10758750003198 | ANTI-C (ANTI-RH2) (MONOCLONAL) BIOCLONE 1X5ML |
| 10758750003129 | ANTI-A,B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML |
| 10758750003075 | ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML |
| 10758750003020 | ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML |
Trademark Results [BIOCLONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOCLONE 73338972 1224734 Live/Registered |
Johnson & Johnson 1981-11-25 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.