Primary Device ID | 10758750003716 |
NIH Device Record Key | 221a4d87-34b6-49b4-a4c0-de77c9b768ba |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ORTHO |
Version Model Number | 718280 |
Catalog Number | 718280 |
Company DUNS | 068715424 |
Company Name | ORTHO-CLINICAL DIAGNOSTICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
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 | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
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 Issuing Agency | Device ID |
---|---|
GS1 | 10758750003716 [Primary] |
DCF | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2023-06-21 |
Device Publish Date | 2016-08-24 |
10758750012824 | ORTHO VISION™ Max Analyzer (MTS) |
10758750007875 | T. CRUZI ELISA TEST SYSTEM 192T |
10758750007646 | 0.8% POOLED SCREENING CELLS 2X10ML |
10758750007479 | T.CRUZI ELISA Test System 2400T |
10758750007462 | T.CRUZI ELISA Test System 480T |
10758750005338 | ORTHO® HBc ELISA Test System |
10758750005321 | ORTHO® HBc ELISA Test System |
10758750005277 | ORTHO® HCV Version 3.0 ELISA Test System |
10758750005260 | ORTHO® HCV Version 3.0 ELISA Test System |
10758750004188 | Anti-Fyb (Anti-Duffy B) |
10758750004171 | Anti-S |
10758750004164 | Anti-s (small s) |
10758750004133 | Anti-Cw (Anti-rhw1) |
10758750004096 | Anti-k (Anti-Cellano) |
10758750003952 | Ortho® A2 Cells (Pooled Cells) |
10758750003822 | ORTHO® Pooled Screening Cells |
10758750003594 | ANTI-IGG GRN 1X10ML |
10758750003587 | ANTI-IGG GRN 100X10ML |
10758750003556 | ANTI-IGG 1X10ML |
10758750003549 | ANTI-IGG 100X10ML |
10758750003440 | ANTI-N (Rabbit) 1X5ML |
10758750003433 | ANTI-M (Rabbit) 1X5ML |
10758750003426 | ANTI-P1 (Goat) 1X3ML |
10758750003372 | ANTI-K (ANTI-KELL) 1X5ML |
10758750003365 | ANTI-FYA (ANTI-DUFFY A) 1X3ML |
10758750003181 | ANTI-D (Anti-Rho) for Slide and Modified Tube Tests 15X10ML |
10758750007837 | ORTHO® Antibody Enhancement Solution |
10758750007820 | ORTHO® Antibody Enhancement Solution |
10758750004072 | Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control |
10758750032846 | ORTHO Optix™ Reader ID-MTS Gel |
10758750012817 | ORTHO VISION™ Analyzer (MTS) |
10758750012763 | OAS Server for VERSEIA Integrated Processor (VIP) |
10758750005505 | OAS Server - 450 MHz, Refurbished |
10758750005499 | OAS Server for Summit Sample Handling System |
10758750005482 | OAS 400 MHz Workstation Refurbished for Summit Sample Handling System |
10758750013265 | ORTHO VERSEIA™ Pipetter |
10758750011599 | ORTHO VERSEIA™ Pipetter Workstation - monitor, accessories |
10758750011582 | ORTHO VERSEIA™ Pipetter Workstation - computer |
10758750007523 | Auto Reader IV |
10758750006014 | Ortho ProVue™ Refurbished |
10758750005581 | Ortho Summit Processor (OSP) |
10758750005451 | OSP Workstation, 166 MHz (computer) |
10758750005420 | AutoWash 96, SLT/AutoWash 96, SLT, Refurbished |
10758750033348 | ORTHO® HCV Version 3.0 ELISA Test System |
10758750033331 | ORTHO® HCV Version 3.0 ELISA Test System |
20758750030900 | Ortho 7% BSA (12 ML) |
20758750030740 | Ortho 7% BSA (5 ML) |
10758750007745 | T. CRUZI ELISA TEST SYSTEM 192T WW |
10758750007554 | ORTHO® Confidence System |
10758750003754 | ORTHO® Bovine Albumin Solution Polymerized Bovine Solution |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHO 98754368 not registered Live/Pending |
OMS Investments, Inc. 2024-09-17 |
ORTHO 97669325 not registered Live/Pending |
Rain Technology, Inc. 2022-11-09 |
ORTHO 97278575 not registered Live/Pending |
OMS Investments, Inc. 2022-02-22 |
ORTHO 97278574 not registered Live/Pending |
OMS Investments, Inc. 2022-02-22 |
ORTHO 97254132 not registered Live/Pending |
OMS Investments, Inc. 2022-02-04 |
ORTHO 97246067 not registered Live/Pending |
OMS Investments, Inc. 2022-01-31 |
ORTHO 97246058 not registered Live/Pending |
OMS Investments, Inc. 2022-01-31 |
ORTHO 97246057 not registered Live/Pending |
OMS Investments, Inc. 2022-01-31 |
ORTHO 87789549 not registered Live/Pending |
OMS Investments, Inc. 2018-02-08 |
ORTHO 87756468 5712274 Live/Registered |
Ortho Mattress Inc. 2018-01-16 |
ORTHO 87554652 not registered Live/Pending |
OMS Investments, Inc. 2017-08-03 |
ORTHO 86871734 not registered Dead/Abandoned |
Zinus Inc. 2016-01-11 |