ORTHO 715480

GUDID 10758750003419

ORTHO® Rh-hr Control (Human and Bovine)

ORTHO-CLINICAL DIAGNOSTICS, INC.

Antisera matrix (non-reactive) IVD, control

• Primary Device ID: 10758750003419
• NIH Device Record Key: f74966c6-13bc-48a0-8dee-46b76a98e5c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO
• Version Model Number: 715480
• Catalog Number: 715480
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10758750003419 [Primary]

FDA Product Code

• DGR: WHOLE HUMAN SERUM, ANTIGEN, ANTISERUM, CONTROL

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: 2023-06-21
• Device Publish Date: 2016-08-24

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• 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