You are on page 1of 5

Document Title: MSDS No.

: Issued Date:
Material Safety Data Sheet SDS-FA-001 09.03.2022

Item Title:
Stained Antigen Agglutination Reagents: Febrile Antigen Reagents and Kits

Contents
1. General Information.
2. Composition, Information on Active Ingredients.
3. Hazard Identification.
4. Fire & Explosion Hazard Data.
5. First Aid Measures.
6. Accidental Release Measures.
7. Handling and Storage.
8. Exposure Control and Personal Gear.
9. Physical and Chemical Properties.
10. Stability and Reactivity Data.
11. Toxicological Information.
12. Ecological Information.
13. Waste Disposal Information.
14. Transport Information.
15. Regulatory Information.
16. Other Information.
17. Disclaimer.

Page 1 of 5
Document Title: MSDS No.: Issued Date:
Material Safety Data Sheet SDS-FA-001 09.03.2022

Item Title:
Stained Antigen Agglutination Reagents: Febrile Antigen Reagents and Kits

1. General Information.

Trade Names & Synonyms: Febrile Antigen Reagents and Kits


Chemical Family: Stained Antigens Agglutination Reagents
Intended use: In-Vitro Diagnostic Reagent for Professional Use.
Formula: Not Applicable.
Manufacturer: VeroTest Sdn. Bhd.
(Formerly known as Atlas Biotech Sdn. Bhd.)
Manufacturer’s address: Unit G-E-2A, Enterprise 4, Technology Park Malaysia,
Lebuhraya Puchong – Sungai Besi, Bukit Jalil,
57000 Kuala Lumpur - Malaysia

2. Composition, Information on Active Ingredients.


• The Febrile Antigen Reagents and Kits is a slide agglutination test for the qualitative and
semi-quantitative detection of bacterial agglutinins in bacterial infection.
• The Febrile Antigen Reagents and Kits may contain some of the following antigens:
• Brucella Abortus, Melitensis and Suis
• Proteus OXK, OX2 and OX19
• Salmonella OA, OB, OC and OD Reagent
• Salmonella HA, HB, HC and HD Reagent
• Positive Control Anti-serum
• Negative Control Anti-serum
• All reagent contains 0.5% of phenol or 0.5% of formalin.
• The controls are stabilized with glycerin and contain 0.01% of Merthiolate.

3. Hazard Identification
Classification of substances or mixture:
• Classification according to Regulation (EC) No. 1272/2008:
H302: Harmful if swallowed.
• Label Elements:
None of labeling requirements stipulated by Regulation (EC) No. 1272/2008 is applicable
to Febrile Antigen Reagents and Kit because it contains low concentration of sodium
azide.
• The control component(s) in each of the above products contain(s) materials derived from
human or animal sources. The source material used to prepare these controls are tested by
an approved method for the presence of human immunodeficiency virus (HIV) as well as
for Hepatitis B surface antigen; and only those materials found to be negative (not
repeatedly reactive) are used to prepare products for sale.

Page 2 of 5
Document Title: MSDS No.: Issued Date:
Material Safety Data Sheet SDS-FA-001 09.03.2022

Item Title:
Stained Antigen Agglutination Reagents: Febrile Antigen Reagents and Kits

4. Fire & Explosion Hazard Data.


• Non-flammable
• Using the reagents according to protocol should not incur a fire or explosion hazard. In
case of fire, use water, foam, carbon dioxide, or dry chemical, as suitable for the
surrounding fire and materials.

5. First Aid Measures


• Eye contact: Wash with water for several minutes.
• Ingestion: Unlikely if used as directed, but possible through hand to mouth contact. If
conscious, rinse mouth with water and obtain medical attention.
• Skin contact: Wash with soap and water immediately.
• Penetrating injury: Remove sharp object, if possible, then wash using clean water. If
still bleeding, obtain medical attention.
• Inhalation: Unlikely in normal use but possible through spray or aerosol formation.
Remove victim to fresh air and obtain medical attention immediately.

6. Accidental Release Measures


• Personal Precautions: Wear protective clothing, rubber, or plastic gloves. Avoid all
direct contact with the product.
• Environmental Precautions: Do not allow enter surface or ground water.
• Spill Clearance: Absorb the spillage using an absorbent material. Place absorbed spill
containing glass or sharp objects in a sharp bin. After clearing, wash the affected area
with disinfectant. Wipe the area until clean and dry.

7. Handling and Storage


• Information for Safe Handling: Keep out of reach of children.
• Storage: Store in the original container at 2-8 °C.
• Requirements to-be-met by Storerooms and Receptacles: No special requirements.

8. Exposure Control and Personal Gear


• Ingredients with Limit Values that Require Monitoring in the Workplace: These
products do not contain any relevant quantities of materials with critical values that have
to be monitored in the workplace.
• General Protective and Hygienic Measures: Adhere to good laboratory practices
(GLP). Wash hands before breaks and at the end of work.
• Protection of Hands: Disposable gloves.
• Material of Gloves: Latex/natural rubber.
• Penetration Time of Glove Material: Glove resistance is not critical as the gloves are
intended to provide protection against the sample material.
• Eye Protection: Not required.

Page 3 of 5
Document Title: MSDS No.: Issued Date:
Material Safety Data Sheet SDS-FA-001 09.03.2022

Item Title:
Stained Antigen Agglutination Reagents: Febrile Antigen Reagents and Kits

• Body Protection: Lab coat.


• Exposure Controls: Avoid splashing and generating sprays. Avoid all direct contact.

9. Physical and Chemical Properties


• General Information:
• Antibodies are formed in human infection cases with various microbiological agents.
Mixing these antibodies with the corresponding homologous antigens causes
agglutination under controlled conditions. The agglutination is macroscopically visible.
For screening purposes, the antigens can be used in the qualitative rapid slide test.
Positive results can be confirmed with the quantitative tube test to verify the antibody
titer.
• Appearance:
Form: Liquid
Colour: Blue or red reagents
Positive and Negative Controls: Yellowish
• Odour: Odourless.
• Flash point: Not applicable.
• Self-igniting: Product is not self-igniting.
• Danger of Explosion: Product does not present an explosion hazard.
10. Stability and Reactivity Data
• Stability: The product is stable in accordance with the recommended storage conditions.
• Materials to be Avoided: None.
• Hazardous Reactions: No dangerous reactions known.
• Hazardous Decomposition Products: No dangerous decomposition products known.
• Stable until expiry date stated on the vial if stored according to manufacturers’
recommendation

11. Toxicological Information


• Acute toxicity: Quantitative data on the toxic effects of this product is not available.
• After skin contact: No irritating effects known.
• After eye contact: No irritating effects known.
• Sensitization: No sensitizing effects known.

12. Ecological Information


• Environmental Toxicity:
Quantitative data on the toxic effects of this product is not available.
• Incorrect sample and used kit disposable:
Bio-hazards may exert cumulative environmental effects due to chemicals and biological
materials present in the test kit.
Page 4 of 5
Document Title: MSDS No.: Issued Date:
Material Safety Data Sheet SDS-FA-001 09.03.2022

Item Title:
Stained Antigen Agglutination Reagents: Febrile Antigen Reagents and Kits

13. Waste Disposal Information


• Product:
When disposing of reagents that contain sodium azide, flush down the drain with copious
amounts of tap water to prevent the build-up of explosive residues in the plumbing. As
this reagent is of animal origin, care must be taken during disposal, as there is a potential
infection risk. Follow local and national guidelines on waste disposal.

• Packaging:
Disposal must be made in accordance with local waste management regulations.
Non-contaminated packaging materials may be recycled. Contact your local service
providers for further information.

14. Transport Information


The product is not subject to transport regulations. The product can be shipped as general cargo
as it withstands the high temperatures for around 7 days. A label should be affixed to the outside
of the package - “Refrigerate upon Arrival”.

15. Regulatory Information


Not applicable.

16. Other Information


• The product is for in-vitro use only.
• Training device: These products are intended for use by healthy person trained in the
handling and use of chemical and biological materials.
• Recommended uses and restriction: these products are intended for professional In-
Vitro Use in the way described in the instruction supplied with the item.
• Advice to product user: The information contained in this safety data sheet is believed to
be correct at the time of preparation. However, because the hazardous properties of many
materials have not been fully evaluated, this sheet is for guidance only and is not claimed
to be fully comprehensive.

17. Disclaimer
The information above is believed to be accurate and represents the best information currently
available to us.

However, we make no warranty of merchantability, or any other warranty expressed or implied,


with respect to such information, and we assume no liability resulting from its use. Users should
make their own investigations to determine the suitability of the information for their particular
purpose. In no way shall the company be liable for any claims, losses or damages of any third
party or for lost profits or any special, indirect, incidental, consequential or exemplary damages,
howsoever arising, even if the company has been advised of the possibility of such damages.

Page 5 of 5

You might also like