Identification
Product identifiers, regulatory numbers, and supplier information
Product Information
- Product Name
- ROTEM® sigma complete
- Product Code
- 555501
Regulatory Identifiers
- CAS Number
- N/A
Identified Uses
Kit component of in vitro diagnostic test for the examination of the blood coagulation system.
Manufacturers & Suppliers
Tem Innovations GmbH
manufacturer
Martin-Kollar-Strasse 13-15, D-81829 Munich, Germany
+49 (0)89 454295 0
Emergency Contacts
Toxicological Information Centre Munich
+49 (0)89 19240
24h/7d
EN
Hazard Identification
GHS classification, signal word, pictograms, and hazard statements
Hazard Classifications
GHS Pictograms
GHS07
Hazard Statements
Precautionary Statements
Get a free compliance audit
Upload your SDS inventory and get a detailed compliance report
Composition / Information on Ingredients
Chemical components, concentration ranges, and hazardous substance identification
ROTEM sigma complete (555501) consists of 20 cartridges and includes the following components: Bead Type Calcium chloride (Emerald Green), Bead Type Recombiplastin (Red), Bead Type APTT (Blue), Bead Type Cytochalasin (Fuchsia), Bead Type Tranexamic acid (Magenta), Bead Type Polybrene (Yellow).
| Chemical Name | CAS Number | Concentration | Hazardous |
|---|---|---|---|
| tranexamic acid EC: 214-818-2 | 1197-18-8 | 10 - 25% | Yes |
| polybrene | 28728-55-4 | 1 - 2.5% | Yes |
| sodium hydroxide EC: 215-185-5 | 1310-73-2 | 1 - 2.5% | Yes |
| phenol EC: 203-632-7 | 108-95-2 | 0.1 - 1% | Yes |
| boric acid EC: 233-139-2 | 10043-35-3 | 0.1 - 1% | Yes |
| sodium azide EC: 247-852-1 | 26628-22-8 | 0.1% | Yes |
For the wording of the listed risk phrases refer to section 16.
Notes
The components contain the substances listed below with nonhazardous additions (concentrations indicated refer to the individual "beads").
First Aid Measures
Emergency procedures for chemical exposure incidents
Move individual to fresh air, seek medical advice in case of complaints.
Immediately wash with water and soap and rinse thoroughly.
Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.
If symptoms persist consult doctor.
Firefighting Measures
Extinguishing media, specific hazards, and firefighter protection
CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.
No further relevant information available.
Firefighter Protection
No special measures required.
Accidental Release Measures
Spill cleanup procedures, containment, and environmental protection
Not required.
No special measures required.
Pick up mechanically.
Related Products
Similar products with comparable safety profiles
Handling and Storage
Safe handling precautions, storage conditions, and workplace requirements
No special measures required.
Store at room temperature. Keep container tightly sealed.
No special measures required.
Exposure Controls / PPE
Occupational exposure limits, engineering controls, and protective equipment
Protective gloves
Tightly sealed goggles
Not required.
Do not allow to enter sewers/ surface or ground water.
Physical and Chemical Properties
Appearance, physical state, melting point, boiling point, and material characteristics
Stability and Reactivity
Chemical stability, hazardous reactions, and incompatible materials
No decomposition if used according to specifications.
No further relevant information available.
No dangerous reactions known.
No further relevant information available.
Avoid contact with strong acids.
Sodium azide develops very toxic gases upon contact with acids.
Ecological Information
Environmental toxicity, biodegradation, and bioaccumulation data
The data for this section has not been processed yet.
Disposal Considerations
Waste treatment methods, disposal recommendations, and waste codes
Disposal must be made according to official regulations.
Disposal must be made according to official regulations.
Waste Codes
Transport Information
UN numbers, shipping names, transport classes, and regulatory requirements
- UN Number
- Void
- Shipping Name
- Void
- Transport Class
- Void
- Packing Group
- Void
Regulatory Information
Chemical regulations, safety assessments, and compliance status
Frequently Asked Questions
Common questions about safety, handling, and properties
What is the hazard signal word for ROTEM® sigma complete?
The signal word is warning.
What is the physical form of ROTEM® sigma complete?
ROTEM® sigma complete is a solid appearing as coloured with coloured color. It has characteristic odor.
What is ROTEM® sigma complete used for?
Kit component of in vitro diagnostic test for the examination of the blood coagulation system.
What are the hazard statements for ROTEM® sigma complete?
This substance has 2 hazard statements:
- H315: Causes skin irritation.
- H319: Causes serious eye irritation.
What is the melting point of ROTEM® sigma complete?
The melting point is Not determined. and the boiling point is Not determined..