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Results for “STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR”

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Registry EUDAMED FDA 510(k) incl. De Novo 2 FDA PMA GUDID 1

Country / market United States 3

Risk class Class I Class IIa Class IIb Class III Class II (US) 3

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Class A Class B Class C Class D IVD General 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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3 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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SteriTec Smart-Read Biological Test Pack with Instant Readout Integrator BI 108

Steritec Product Mfg. Co., Inc.,FDA registration: United States

None Registry: GUDID Class:II
Steritec Smart-Read Biological Test Pack With Instant Readout Integrator

Steritec Products Mfg Co, Inc.,FDA registration: United States Group of variants

Active Regimes: 510(k) Registry: 510(k) Class:II

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