Genetic testing (EMDN W0106) — medical devices

NeoNat SCID-SMA Multiplex Real-Time PCR Kit

Labsystems Diagnostics OyFinland IVD General

NeoNat SCID-SMA Real-Time PCR Kit

Labsystems Diagnostics OyFinland IVD General

NeoNat SCID-SMA Real-Time PCR Kit

Labsystems Diagnostics OyFinland IVD General

NeoNat SMA Real-Time PCR Kit

Labsystems Diagnostics OyFinland IVD General

NeoNat SCID-SMA Multiplex Real-Time PCR Kit

Labsystems Diagnostics OyFinland IVD General

TRUPCR® BCR-ABL1 Qualitative Kit – Major, Minor & Micro

3B BlackBio Dx LimitedIndia Class C

Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence P…

PSI Gene Technology Co., Ltd.China IVD General

NeoNat SCID Real-Time PCR Kit

Labsystems Diagnostics OyFinland IVD General

Resistant Gene KPC and CMY-2 Diagnostic Kit (PCR-Fluorescence Probing)

Sansure Biotech Inc.China IVD General

NeoNat SCID Real-Time PCR Kit

Labsystems Diagnostics OyFinland IVD General

QuantideX qPCR BCR-ABL minor Kit

Asuragen, Inc.United States IVD General

Eonis SCID-SMA kit

Wallac OyFinland Class C

NeoNat SMA Real-Time PCR Kit

Labsystems Diagnostics OyFinland IVD General

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

PSI Gene Technology Co., Ltd.China IVD General

Resistant Gene KPC and CMY-2 Diagnostic Kit (PCR-Fluorescence Probing)

Sansure Biotech Inc.China IVD General

gb GENETIC LACTO

GENERI BIOTECH s.r.o.Czechia IVD General

EnLite Neonatal TREC kit

Wallac OyFinland IVD General

TRUPCR® BCR-ABL1 Minor Quantitative Kit

3B BlackBio Dx LimitedIndia Class C

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

PSI Gene Technology Co., Ltd.China IVD General

TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor & Micro

3B BlackBio Dx LimitedIndia Class C

Genetic testing

Subcategories4

Devices

NeoNat SCID-SMA Multiplex Real-Time PCR Kit

NeoNat SCID-SMA Real-Time PCR Kit

NeoNat SCID-SMA Real-Time PCR Kit

NeoNat SMA Real-Time PCR Kit

NeoNat SCID-SMA Multiplex Real-Time PCR Kit

TRUPCR® BCR-ABL1 Qualitative Kit – Major, Minor & Micro

Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence P…

NeoNat SCID Real-Time PCR Kit

Resistant Gene KPC and CMY-2 Diagnostic Kit (PCR-Fluorescence Probing)

NeoNat SCID Real-Time PCR Kit

QuantideX qPCR BCR-ABL minor Kit

Eonis SCID-SMA kit

NeoNat SMA Real-Time PCR Kit

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

Resistant Gene KPC and CMY-2 Diagnostic Kit (PCR-Fluorescence Probing)

gb GENETIC LACTO

EnLite Neonatal TREC kit

TRUPCR® BCR-ABL1 Minor Quantitative Kit

Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor & Micro