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Results for “One Step Shigella Test”

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Registry EUDAMED 6 FDA 510(k) FDA PMA GUDID 2

Country / market European Union (all) 6 United States 2

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Germany 6

Risk class Class I Class IIa Class IIb Class III Class II (US) 2

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Class A Class B Class C Class D IVD General 6 IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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8 devices foundsorted by relevance

Device · Manufacturer · Authorizations

One Step Shigella Test UDI-DI D-L11-SH02C66Z

Newlink Biotech co., Ltd.,China IVD General

Active CE IVDD EUDAMED IVD General
2 variants
- One Step Shigella Test L11-SH02F6
One Step Shigella Flexneri Antigen Test UDI-DI D-L11-SHF01F62J

Newlink Biotech co., Ltd.,China IVD General

Active CE IVDD EUDAMED IVD General
2 variants
- One Step Shigella Flexneri Antigen Test L11-SHF01C6
One Step Shigella Sonnei Antigen Test UDI-DI D-L11-SHS01F66Z

Newlink Biotech co., Ltd.,China IVD General

Active CE IVDD EUDAMED IVD General
2 variants
- One Step Shigella Sonnei Antigen Test L11-SHS01C6
EZ-SHIGELLA One-Step Shigella species Rapid Test 1009-15 UDI-DI 00083059100952

Biomerica, Inc.,United States Class II

None GUDID II
2 variants
- EZ-SHIGELLA One-Step Shigella species Rapid Test 1009-15 1009-15 Withdrawn

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