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Safety Data Sheet EN

Xpert MTB/RIF; Xpert MTB/RIF Ultra; Xpert MTB/XDR

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
Xpert MTB/RIF; Xpert MTB/RIF Ultra; Xpert MTB/XDR
Product Code
GXMTB/RIF-10; GXMTB/RIF-50; GXMTB/RIF-CN-10; GXMTB/RIF-US-10; GXMTB/RIF-JP-10; CGXMTB/RIF-10; CGXMTB/RIF-50; GXMTB/RIF-ULTRA-10; GXMTB/RIF-ULTRA-50; GXMTB/RIF-IN-10; CGXMTB/RIF-IN-50; 900-0772; GXMTB/RIF-ULT-SA50; GXMTB/RIF-MII-10; GXMTB/RIF-MII-50; 900-0779; 900-0811; RMTB/XDR-10; GXMTB-ULTRA-MII-10; GXMTB-ULTRA-MII-50; GXMTB/XDR-10; 900-0888; OMNIMTB/RIF-ULT-10; GXMTBRIF-ULT-CN-10; GXMTBRIF-ULT-CN-50

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Laboratory use

Manufacturers & Suppliers

Cepheid logo

Cepheid

manufacturer

904 Caribbean Drive, Sunnyvale, CA 94089, United States

(888) 838-3222

http://www.cepheid.com

Cepheid AB logo

Cepheid AB

manufacturer

Röntgenvägen 5, SE-171 54 Solna, Sweden

+33 563 825 319

http://www.cepheidinternational.com

Cepheid India Private Limited logo

Cepheid India Private Limited

manufacturer

1, SIPCOT Industrial Growth Centre, Oragadam, Kanchipuram, Tamil Nadu - 602 105, India

+91 11 48353010

http://www.cepheidinternational.com

Cepheid Holdings Pty Ltd logo

Cepheid Holdings Pty Ltd

manufacturer

Suite 2, Level 3, Building A, 11 Talavera Road, Macquarie Park, NSW 2113, Australia

1800 107 884

http://www.cepheidinternational.com

Emergency Contacts

INFOTRAC

1 (800) 535-5053

24 hr Emergency

Manufacturer

1 (352) 323-3500

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified danger

Hazard Classifications

Flam. Liq. Cat. 3 H226
Skin Corr. Cat. 1B H314

GHS Pictograms

GHS02 - Flammable

GHS02

GHS05 - Corrosive

GHS05

Hazard Statements

H226 Flammable liquid and vapour
H314 Causes severe skin burns and eye damage.
H318 Causes serious eye damage
H341 Suspected of causing genetic defects.
H361 Suspected of damaging fertility or the unborn child.
H373 May cause damage to organs through prolonged or repeated exposure.

Precautionary Statements

P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been read and understood.
P210 Keep away from heat, sparks, open flames and/or hot surfaces. - No smoking.
P233 Keep container tightly closed.
P260 Do not breathe mists, vapours, and/or spray.
P264 Wash thoroughly after handling.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P281 Use personal protective equipment as required.
P301 + P330 + P331 IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.
P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P310 Immediately call a POISON CENTER or doctor/physician.
P314 Get medical advice/attention if you feel unwell.
P321 Specific treatment, see supplemental first aid information.
P363 Wash contaminated clothing before reuse.
P370 + P378 In case of fire: Use appropriate media for extinction.
P501 Dispose of content and/or container in accordance with local, regional, national, and/or international regulations.

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type Mixture

Material does not meet the criteria of a substance in accordance with Regulation (EC) No 1272/2008.

Chemical Name CAS Number Concentration Hazardous
Isopropyl alcohol EC: 200-661-7 67-63-0 10 - 15% Yes
Sodium hydroxide EC: 215-185-5 1310-73-2 5 - 8% Yes

Safety Data Sheet Effective Date: 2023-06 Supersedes: 2022-4 Xpert MTB/RIF Xpert MTB/RIF Ultra Xpert MTB/XDR Xpert Omni MTB/RIF Ultra

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Remove to fresh air. Administer oxygen if breathing is difficult. Give artificial respiration if victim is not breathing. If signs/symptoms continue, get medical attention.

Skin contact

Wash skin with soap and water. Get medical attention.

Eye contact

Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first five minutes, then continue rinsing eye. Get medical attention.

Ingestion

Rinse mouth. Never give anything by mouth to an unconscious person. Get medical attention.

Immediate Medical Attention

All treatments should be based on observed signs and symptoms of distress in the patient.

Medical Treatment

All treatments should be based on observed signs and symptoms of distress in the patient.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Use water spray (fog), foam, dry powder, or carbon dioxide.

Unsuitable media

No data available

Specific hazards

This material is classified flammable, however it is in small vials and is unlikely to cause significant flammability hazard in use.

Firefighter Protection

Fire fighters should wear complete protective clothing including self-contained breathing apparatus.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

No emergency procedures are expected to be necessary if material is used under ordinary conditions as recommended.

Small spill

For small spills, wear gloves and absorb spill with paper towel. Do not dispose spilled materials down drain.

Environmental

Prevent entry into waterways, sewers, basements or confined areas.

Cleanup methods

absorb spill with paper towel.

Materials: paper towel

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Use good safety and industrial hygiene practices. Use appropriate Personal Protective Equipment (PPE). Avoid contact with skin and eyes.

Storage

Store according to product labeling.

Hygiene

Wash thoroughly with soap and water after handling and before eating, drinking, or using tobacco.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Good general ventilation should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level.

Eyes

Wear chemical splash safety goggles.

Respiratory

Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or symptoms are experienced.

Skin/Body

Wear protective clothing

Environmental

Follow best practice for site management and disposal of waste.

09

Physical and Chemical Properties

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

Dynamic Viscosity
---
Colour Intensity
---
Odor
Data lacking
Cloud Point
---
Solidification Point
---
Properties Status
---
Boiling Point
Data lacking
Auto Ignition Temperature
No data available
Physical State Data
liquid
Bulk Density
---
Decomposition Temperature
Data lacking
Density
---
Metal Corrosion
---
Crystallisation Point
---
Upper Explosive Limit
No data available
Freezing Point
Data lacking
Relative Evaporation Rate
---
Softening Point
---
Solubility In Water
Data lacking
Voc Content
---
Kinematic Viscosity
---
Solubility
---
Flash Point
Sample Reagent: 20
Odor Threshold
Data lacking
Ph
> 12.5
Lower Explosive Limit
No data available
Melting Point
Data lacking
Vapor Pressure
Data lacking
Relative Density
Data lacking
Evaporation Rate
Data lacking
Vapor Density
Data lacking
Explosive Limits
---
Molecular Weight
---
Appearance
Beads are solid white components in cartridges; reagents are clear liquids which are primarily buffered in aqueous solutions. Components are odorless.
Colour
White/clear
Form
---
Physical State
Liquid
Solubility In Fat
---
State Under Standard Conditions
---
Flammability
No data available
Partition Coefficient
Data lacking
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

Stable under normal temperatures and pressures.

Reactivity

No dangerous reaction known under conditions of normal use.

Hazardous reactions

Isopropyl alcohol may form explosive mixture in air. For all other ingredients, no potential for hazardous reactions identified.

Avoid

Heat, flames, sparks.

Incompatible

Acids, oxidizing agents.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

Toxicity

Sample reagent containing sodium hydroxide > 12.5 pH has the potential for harmful effects in the environment if not properly disposed.

Sample reagent containing sodium hydroxide > 12.5 pH has the potential for harmful effects in the environment if not properly disposed.

Persistence and Degradability

Material data lacking.

Material data lacking.

Bioaccumulative Potential

Material data lacking.

Material data lacking.

Mobility in Soil

Material data lacking.

Material data lacking.

Results of PBT and vPvB assessment

No PBT and vPvB assessment has been conducted.

No PBT and vPvB assessment has been conducted.

Other Adverse Effects

No studies have been found.

No studies have been found.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

Dispose of content and/or container in accordance with local, regional, national, and/or international regulations.

Disposal

Dispose of content and/or container in accordance with local, regional, national, and/or international regulations.

14

Transport Information

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

UN Number
UN2920
Shipping Name
Corrosive liquids, flammable, n.o.s. (sodium hydroxide, isopropanol)
Transport Class
8,3
Packing Group
II
IMDG

None specified.

IATA

None specified.

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

Chemical Safety Assessment Not performed

SARA Hazard Classifications Acute, Chronic, Fire

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Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for Xpert MTB/RIF; Xpert MTB/RIF Ultra; Xpert MTB/XDR?

The signal word is danger.

What is the physical form of Xpert MTB/RIF; Xpert MTB/RIF Ultra; Xpert MTB/XDR?

Xpert MTB/RIF; Xpert MTB/RIF Ultra; Xpert MTB/XDR is a liquid appearing as beads are solid white components in cartridges; reagents are clear liquids which are primarily buffered in aqueous solutions. components are odorless. with white/clear color. It has data lacking odor.

What is Xpert MTB/RIF; Xpert MTB/RIF Ultra; Xpert MTB/XDR used for?

Laboratory use

What are the hazard statements for Xpert MTB/RIF; Xpert MTB/RIF Ultra; Xpert MTB/XDR?

This substance has 6 hazard statements:

  • H226: Flammable liquid and vapour
  • H314: Causes severe skin burns and eye damage.
  • H318: Causes serious eye damage
  • H341: Suspected of causing genetic defects.
  • H361: Suspected of damaging fertility or the unborn child.
  • H373: May cause damage to organs through prolonged or repeated exposure.

What is the melting point of Xpert MTB/RIF; Xpert MTB/RIF Ultra; Xpert MTB/XDR?

The melting point is Data lacking and the boiling point is Data lacking.