ORTHO 6842222

GUDID 10758750032846

ORTHO Optix™ Reader ID-MTS Gel

ORTHO-CLINICAL DIAGNOSTICS, INC.

Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD Agglutination assay digital imaging reader/analyser IVD
Primary Device ID10758750032846
NIH Device Record Keyad012eaa-a42f-42f4-aa74-60ac5630dae9
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHO
Version Model Number6842222
Catalog Number6842222
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 Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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 -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius
Storage Environment TemperatureBetween -23.3 Degrees Celsius and 65.5 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110758750032846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSZSYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-15
Device Publish Date2021-04-07

On-Brand Devices [ORTHO]

10758750012824ORTHO VISION™ Max Analyzer (MTS)
10758750007875T. CRUZI ELISA TEST SYSTEM 192T
107587500076460.8% POOLED SCREENING CELLS 2X10ML
10758750007479T.CRUZI ELISA Test System 2400T
10758750007462T.CRUZI ELISA Test System 480T
10758750005338ORTHO® HBc ELISA Test System
10758750005321ORTHO® HBc ELISA Test System
10758750005277ORTHO® HCV Version 3.0 ELISA Test System
10758750005260ORTHO® HCV Version 3.0 ELISA Test System
10758750004188Anti-Fyb (Anti-Duffy B)
10758750004171Anti-S
10758750004164Anti-s (small s)
10758750004133Anti-Cw (Anti-rhw1)
10758750004096Anti-k (Anti-Cellano)
10758750003952Ortho® A2 Cells (Pooled Cells)
10758750003822ORTHO® Pooled Screening Cells
10758750003594ANTI-IGG GRN 1X10ML
10758750003587ANTI-IGG GRN 100X10ML
10758750003556ANTI-IGG 1X10ML
10758750003549ANTI-IGG 100X10ML
10758750003440ANTI-N (Rabbit) 1X5ML
10758750003433ANTI-M (Rabbit) 1X5ML
10758750003426ANTI-P1 (Goat) 1X3ML
10758750003372ANTI-K (ANTI-KELL) 1X5ML
10758750003365ANTI-FYA (ANTI-DUFFY A) 1X3ML
10758750003181ANTI-D (Anti-Rho) for Slide and Modified Tube Tests 15X10ML
10758750007837ORTHO® Antibody Enhancement Solution
10758750007820ORTHO® Antibody Enhancement Solution
10758750004072Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control
10758750032846ORTHO Optix™ Reader ID-MTS Gel
10758750012817ORTHO VISION™ Analyzer (MTS)
10758750012763OAS Server for VERSEIA Integrated Processor (VIP)
10758750005505OAS Server - 450 MHz, Refurbished
10758750005499OAS Server for Summit Sample Handling System
10758750005482OAS 400 MHz Workstation Refurbished for Summit Sample Handling System
10758750013265ORTHO VERSEIA™ Pipetter
10758750011599ORTHO VERSEIA™ Pipetter Workstation - monitor, accessories
10758750011582ORTHO VERSEIA™ Pipetter Workstation - computer
10758750007523Auto Reader IV
10758750006014Ortho ProVue™ Refurbished
10758750005581Ortho Summit Processor (OSP)
10758750005451OSP Workstation, 166 MHz (computer)
10758750005420AutoWash 96, SLT/AutoWash 96, SLT, Refurbished
10758750033348ORTHO® HCV Version 3.0 ELISA Test System
10758750033331ORTHO® HCV Version 3.0 ELISA Test System
20758750030900Ortho 7% BSA (12 ML)
20758750030740Ortho 7% BSA (5 ML)
10758750007745T. CRUZI ELISA TEST SYSTEM 192T WW
10758750007554ORTHO® Confidence System
10758750003754ORTHO® Bovine Albumin Solution Polymerized Bovine Solution

Trademark Results [ORTHO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHO
ORTHO
97669325 not registered Live/Pending
Rain Technology, Inc.
2022-11-09
ORTHO
ORTHO
97278575 not registered Live/Pending
OMS Investments, Inc.
2022-02-22
ORTHO
ORTHO
97278574 not registered Live/Pending
OMS Investments, Inc.
2022-02-22
ORTHO
ORTHO
97254132 not registered Live/Pending
OMS Investments, Inc.
2022-02-04
ORTHO
ORTHO
97246067 not registered Live/Pending
OMS Investments, Inc.
2022-01-31
ORTHO
ORTHO
97246058 not registered Live/Pending
OMS Investments, Inc.
2022-01-31
ORTHO
ORTHO
97246057 not registered Live/Pending
OMS Investments, Inc.
2022-01-31
ORTHO
ORTHO
87789549 not registered Live/Pending
OMS Investments, Inc.
2018-02-08
ORTHO
ORTHO
87756468 5712274 Live/Registered
Ortho Mattress Inc.
2018-01-16
ORTHO
ORTHO
87554652 not registered Live/Pending
OMS Investments, Inc.
2017-08-03
ORTHO
ORTHO
86871734 not registered Dead/Abandoned
Zinus Inc.
2016-01-11
ORTHO
ORTHO
86093761 4537548 Live/Registered
OMS Investments, Inc.
2013-10-17

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