[MP 13,620] SCHEDULE (Regulation 2)LIST OF PRODUCTS SAFE FOR GENERAL USE

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SARS-COV-2 Antigen Rapid Diagnostic Tests
Product NameName of Manufacturer/ SupplierCountry of ManufactureWHO-EUL/TGA APPROVAL
1CareStart™ COVID-19 AntigenACCESS BIO INC, 65 CLYDE RD, SUITE A, SOMERSET NJ 08873, USAUSATGA
2InnoScreen Covid-19 Antigen Rapid Test DeviceInnovation Scientific Pty LtdAustraliaTGA
3InnoScreen COVID-19 Antigen Rapid Test DeviceInnovation Scientific Pty LtdAustraliaTGA
4Panbio Covid-19 Ag Rapid Test Device (Nasal)ABBOTT RAPID DIAGNOSTICS-Jena GmbHKoreaWHO-EUL
5Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)ABBOTT RAPID DIAGNOSTICS-Jena GmbHKoreaWHO-EUL
6SARS COV-2 Antigen rapid Test kitsBiohit Healthcare (Hefei) Co., LtdChinaTGA
7SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay)Biohit Healthcare (Hefei) Co., LtdChinaTGA
8SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method)Biohit Healthcare (Hefei) Co., LtdChinaTGA
SARS-CoV-2 Antigen Self-Test NasalSD Biosensor, INC., C-4/5 Floor 16, Deogyeong-daeroKoreaTGA
91556 beong-gil, Yeongtong-10gu, Suwon-si Geyonggi-do 16690.
10SARS-CoV-2 Rapid Antigen TestSD Biosensor, INCKoreaTGA
11STANDARD™ Q COVID-19 Ag TestSD Biosensor, INCKoreaWHO EUL /TGA
12Sure Status Covid-19 Antigen Card TestPremier Medical Corporation Private LimitedIndiaWHO-EUL
13VivaDiag™ SARS-CoV-2 Ag Rapid TestVivaChek Biotrch (Hangzhou) Co. Ltd, Level 2 Block 2 146 EastChaofeng Road Yuhang Economy Development Zone, Hangzhou Zhejiang, 311100ChinaTGA