ImmunoDOT Autoimmunity Screening Panel 1

GenBio

Revision date : 2025-10-31

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GHS08
Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

247-852-1/26628-22-8

Name of the chemical

Sodium Azide

Concentration

N/A

EC/CAS

200-679-5/68-12-2

Name of the chemical

Dimethyl formamide; N,N-dimethylformamide (DMFa)

Concentration

N/A

General Information

Revision date

2025-10-31

Product name

ImmunoDOT Autoimmunity Screening Panel 1

1.2.1 Relevant identified uses

The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories

supplier name

GenBio

Icons in SDS

GHS08 M004 M009 M010 M011 M013 M026 M059

Company Information

company name

GenBio

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H360D+H332+H312+H319

Section 2

SECTION 2: Hazards identification

(2) 1272/2008 This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Specific warnings are given in the instructions for use. The absence of a specific warning should not be interpreted as an indication of safety. Component R1 Assay Strips

Contains

Nitrocellulose membrane on flexible polyvinyl chloride film backing [CAS# 9002- 86-2] consisting of the following antigens spotted onto the nitrocellulose 4 Assemblies (4 X 25 strips) membrane: Human IgG (human serum), total nuclear antigen consisting of purified chicken erythrocyte nuclei and purified bovine nuclear antigens, double- stranded deoxyribonucleic acid (ds-DNA), ribonucleoprotein (RNP) and Smith antigens, Sjogren's syndrome A and B antigens, and negative control. Assay Strips are blocked and preserved with non-fat dry milk [Casein from bovine Flammable Solid milk EINECS/ELINCS No 232-555-1, CAS# 9000-71-9] R2 Diluent 0.01M Phosphate buffer solution with sodium chloride [CAS# 7647-14-5, EINECS/ELINCS No. 231-598-3] and bovine serum albumin [CAS# 9048-46-8, 4 bottles (4 X 50 mL) EINECS/ELINCS No. 232-936-2] (pH 6.2-7.6). Preserved with < 0.1% sodium azide [NaN3], EINECS/ELINCS No: 247-852-1 and CAS# 26628-22-8, dilution below EU regulated labeling levels (1999/45/EC– dilution < 0.1%). R3 Enhancer 4 bottles (4 X 50 mL) Saline solution with sodium chloride [CAS# 7647-14-5, EINECS/ELINCS No. 231- 598-3]. Page 1 of 12 Effective Date 31 October 2025 Preserved with < 0.1% sodium azide [NaN3], EINECS/ELINCS No: 247-852-1 and CAS# 26628-22-8, dilution below EU regulated labeling levels (1999/45/EC– dilution < 0.1%). R4 Conjugate Alkaline Phosphatase labeled goat anti-Human IgG in Tris buffer solution (Tris Base [EINECS/ELINCS No. 201-064-4, CAS# 77-86-1] and Tris-HCl [EINECS/ELINCS 4 bottles (4 X 50 mL) No. 214-684-5, CAS# 1185-53-1]) with 0.012% magnesium sulfate [EINECS/ELINCS No. 231-298-2, CAS# 7487-88-9], 0.0014% Zinc Chloride [EINECS/ELINCS No. 231- 592-0, CAS# 7646-85-7, dilution below concentration limit per directive 98/8/EC], and bovine serum albumin [CAS# 9048-46-8, EINECS/ELINCS No. 232-936-2]. Preserved with < 0.1% sodium azide [NaN3], EINECS/ELINCS No: 247-852-1 and CAS# 26628-22-8, dilution below EU regulated labeling levels (1999/45/EC– dilution < 0.1%). R5 Developer 4 bottles (4 X 50 mL) 0.02% 5-bromo-4-chloro-3-indolyl phosphate [EC No. 229-506-1, CAS# 6578-06-9] and <0.05% p-nitro blue tetrazolium chloride [ EC No. 206-067-4, CAS# 298-83-9] in Tris buffer solution (Tris Base [EINECS/ELINCS No. 201-064-4, CAS# 77-86-1] and Tris-HCl [EINECS/ELINCS No. 214-684-5, CAS# 1185-53-1]) with <1% sodium chloride [CAS# 7647-14-5, EINECS/ELINCS No. 231-598-3], <1% magnesium sulfate [EC No. 231-298-2, CAS# 7487-88-9], and <1% N,N- Dimethylformamide [EC No. 200-679-5, CAS# 68-12-2, WARNING! H360D + H332

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