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Safety Data Sheet EN

Emicizumab Calibrator / Emicizumab Controls

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
Emicizumab Calibrator / Emicizumab Controls
Product Code
151-201 / 152-401

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Calibrator plasma and controls used for assay of Emicizumab activity using a modified one-stage FVIII activity assay. For in-vitro diagnostics use only.

Manufacturers & Suppliers

r2 Diagnostics Inc. logo

r2 Diagnostics Inc.

manufacturer

1801 Commerce Dr., South Bend, IN 46628

www.r2diagnostics.com

Emergency Contacts

Within USA and Canada

+1 (800) 729-5270

Outside USA and Canada

+1 (574) 288-4377

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified no signal word

Hazard Classifications

Not Classified

GHS Pictograms

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture
Chemical Name CAS Number Concentration Hazardous
Lyophilized Citrated plasma EC: 280-593-2 83732-46-1 98% No
Glycine EC: 200-272-2 56-40-6 1% No
Sucrose EC: 200-334-9 57-50-1 1% No
Emicizumab --- 1% No
04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Move person to fresh air. If not breathing, give artificial respiration or give oxygen by trained personnel. Get immediate medical attention.

Skin contact

Immediately wash skin with soap and plenty of water for at least 15 minutes. Remove contaminated clothing. Get medical attention if symptoms occur. Wash clothing before reuse.

Eye contact

Flush eyes with plenty of water for at least 15 minutes. Have eyes examined and tested by medical personnel.

Ingestion

Wash out mouth with water provided person is conscious. Never give anything by mouth to an unconscious person. Get medical attention. Do NOT induce vomiting unless directed to do so by medical personnel.

Immediate Medical Attention

Get immediate medical attention.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Use alcohol-resistant foam, carbon dioxide, water, or dry chemical spray. Use water spray to cool fire-exposed containers.

Unsuitable media

A solid water stream may be inefficient.

Instructions

As in any fire, wear self-contained breathing apparatus pressure-demand (NIOSH approved or equivalent), and full protective gear to prevent contact with skin and eyes

Firefighter Protection

As in any fire, wear self-contained breathing apparatus pressure-demand (NIOSH approved or equivalent), and full protective gear to prevent contact with skin and eyes

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Avoid creating and breathing dust and provide adequate ventilation.

Environmental

Take steps to avoid release into the environment, if safe to do so.

Cleanup methods

Transfer to a chemical waste container for disposal in accordance with local regulations.

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray. Avoid prolonged or repeated exposure.

Storage

Keep container tightly closed. Store in accordance with information listed on the product insert

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Use process enclosures, local exhaust ventilation or other engineering controls to control airborne levels below recommended exposure limits.

Hands

Compatible chemical-resistant gloves

Eyes

Safety glasses

Respiratory

NIOSH approved respirator, as conditions warrant.

Skin/Body

Lab coat

09

Physical and Chemical Properties

Appearance, physical state, melting point, boiling point, and material characteristics

Physical State
Solid (Lyophilized)
Physical State Data
solid
State Under Standard Conditions
---
Appearance
Solid
Colour
---
Colour Intensity
---
Form
---
Odor
---
Odor Threshold
---
Ph
---
Melting Point
No data.
Boiling Point
No data.
Flash Point
No data.
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
No data.
Vapor Pressure
No data.
Vapor Density
No data.
Relative Density
No data.
Bulk Density
---
Density
---
Flammability
---
Upper Explosive Limit
No data.
Lower Explosive Limit
No data.
Explosive Limits
---
Auto Ignition Temperature
No data.
Decomposition Temperature
---
Solubility
---
Partition Coefficient
---
Solubility In Water
No data.
Solubility In Fat
---
Molecular Weight
---
Voc Content
---
Metal Corrosion
---
Dynamic Viscosity
---
Kinematic Viscosity
---
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

Stable if stored in accordance with information listed on the product insert.

Reactivity

No data available.

Hazardous reactions

Will not occur

Avoid

No data available.

Incompatible

No data available.

Decomposition

No data available.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

The data for this section has not been processed yet.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Disposal

Dispose in accordance with local, state, and federal regulations.

14

Transport Information

UN numbers, shipping names, transport classes, and regulatory requirements

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

This SDS was prepared in accordance with 29 CFR 1910.1200 and Regulation (EC) No.1272/2008

Chemical Safety Assessment Not performed
?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for Emicizumab Calibrator / Emicizumab Controls?

The signal word is no signal word.

What is the physical form of Emicizumab Calibrator / Emicizumab Controls?

Emicizumab Calibrator / Emicizumab Controls is a solid (lyophilized) appearing as solid .

What is Emicizumab Calibrator / Emicizumab Controls used for?

Calibrator plasma and controls used for assay of Emicizumab activity using a modified one-stage FVIII activity assay. For in-vitro diagnostics use only.

What is the melting point of Emicizumab Calibrator / Emicizumab Controls?

The melting point is No data. and the boiling point is No data..