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MSDS 60r ryphalb R.pld Tcst ,F 1E (38 PasElof 3

MSDS for Syphilis Rapid Test

I .l.lndentification of the product

Product Name: Syphilis Rapid Test
Brand: RightSign@

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of the preparation
I
The Syphilis Rapid Test is a rapid chromatographic immunoassay for the qualitative
detection of antibodies (lgG and lgM) to Treponema Pallidum (TP) to aid in the diagnosis
of Syphilis.

l .3.Company lndentifiation
Company: Hangzhou Biotest Biotech Co., Ltd.
Address: #17 FutaiRoad, ZhongtaiStreet, Yuhang District, Hangzhou. P.R.China.
311121
Tel: 0086-571 -89058016
Fax0086-571-88633388
E-mail : info@biotests.com.cn
I .4.Emergency telephone No.
Emergency telephone: 0086-571 €905801 6

ll lnformation of lngredients
Sodium Azide Concentration: = <0.02o/o (7.5n9/test)
CAS#:26628-22-8

lll Hazards lndentification

Not dangerous preparation

lV First aid measures

Firstaid personnel: N/A
After inhalation: N/A
After skin contact N/A
After eye contact: N/A
After swallowing: N/A

V. Fire-fighting measu res

lnflammable in contact with flames, not explosive.
Extinguishing media: water or foam

Vl Accidental release ff easure

N/A

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Vll.1. Handling
Good Laboratory Practices(disposal gloves)

Vll.2. Storage
Store in a dry place at +2C to +30C
Avoid storage near to heat sour@s
Accessible only for authorized percons

V I I l. Exposure control s/person al protection

Specirnen collection and preparation : allthe specimens should be considered potentially
hazardous and handled in the same manner as an infectious agent.
Use disposalgloves.

X. Physical and chemical properties

Form: Solid reaction strip that could be placed into a plastic cassette depending on the
format used.
Colour: White solid with red lines.
Odour: N/A
pH value: N/A
Melting point: N/A
lgnition temperature: N/A
Flash point: N/A
Explosion limits: N/A
Density: N/A

X. Stability and reactivity

1. Stable
2. Conditions to be avoided: Strong heating, direct contact with flames.
3. Substances to be avoided: only use provided diluent for sample dilution

Xl. Toxicological information

N/A

Xl l. Ecological information
The Syphilis Rapid Test should be discarded in a proper biohazard epntainer after testing.

Xl I l. Disposal ansideration s
After testing, the Syphilis Rapid Test must be disposed of compliance with the respective
national regulations.

"
XtV. Transport information
Not dangerous preparations, not required transport regulation.
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MSOS for Syphilb R.pld Tesr F3Er(3X Pass3of3

This product does not requare special labeling, in accordance with the appropriate EC
directives.

This product is for in vitro diagnostic use therefore must complie with the European
Directive 98/79/Ec bearing the cE label prior to the placing on the market.

XVl. Other information

For professional in vitro Diagnostic use only. consult instructions for use.

References:
1. REGULATION (EC) No 190712006
2. REGULATION (EC) No 1272t2008
3. tvDD 98/79/EC
4. Claire M. Fraser. Complete genome sequence of Treponema Pallidum, the Syphilis
spirochete, Science 1998; 281 July: 375-381
5. Center for Disease Control. Recommendations for diagnosing and treating Syphilis in
HIV-infected patients, MMWR Morb. Mortal\A/kly Rep. 1988; 37:601
6. Aral R. Max. Crack, sex and STD,Sexually Transmitted Diseases, 1991 ; 18:92-101
7. J.N. Wasserheit. Epidemiological Synergy: lnterrelationships between human
immunodeficiency virus infection and other sexually transmitted diseases, Sexually
Transmitted Diseases 1992; 19:61 -77
8. Johnson Phillip c.Testing for syphilis, Dermatotogic clinic 1gg4;12 Jan: 9-17

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