124 results · 7ms · Sources: EU EUDAMED, US FDA

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Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.

FDA classification
FDA Class 2 ·Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification
FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification
FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

FDA classification
FDA Class 2 ·Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification
FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

Loss Of Pulse Notification Software

FDA classification
FDA Class 2 ·Loss Of Pulse Notification Software

Instrument For Treatment Of Hyperhidrosis

FDA classification
FDA Class 2 ·Instrument For Treatment Of Hyperhidrosis

Red-Cell Count By Photometry

FDA classification
FDA Class 2 ·Red-Cell Count By Photometry

Rhinoanemometer (Measurement Of Nasal Decongestion)

FDA classification
FDA Class 2 ·Rhinoanemometer (Measurement Of Nasal Decongestion)

System, Monitoring, For Progress Of Labor

FDA classification
FDA Class 2 ·System, Monitoring, For Progress Of Labor

Rinse, Oral, Antibacterial (By Physical Means)

FDA classification
FDA Class 2 ·Rinse, Oral, Antibacterial (By Physical Means)

Immunoassay For Host Biomarkers Of Sepsis

FDA classification
FDA Class 2 ·Immunoassay For Host Biomarkers Of Sepsis

Skin Patch For Treatment Of Hyperhidrosis

FDA classification
FDA Class 2 ·Skin Patch For Treatment Of Hyperhidrosis

Catheter, Balloon, Dilation Of Cervical Canal

FDA classification
FDA Class 2 ·Catheter, Balloon, Dilation Of Cervical Canal

Immunoassay For Host Biomarkers Of Infection

FDA classification
FDA Class 2 ·Immunoassay For Host Biomarkers Of Infection

Reagents For Detection Of Norovirus Nucleic Acid

FDA classification
FDA Class 2 ·Reagents For Detection Of Norovirus Nucleic Acid

Prognostic Assessment Software Of Mild Cognitive Impairment

FDA classification
FDA Class 2 ·Prognostic Assessment Software Of Mild Cognitive Impairment

Monitor For Opioid Induced Impairment Of Oxygenation

FDA classification
FDA Class 2 ·Monitor For Opioid Induced Impairment Of Oxygenation

Agents, Embolic, For Treatment Of Uterine Fibroids

FDA classification
FDA Class 2 ·Agents, Embolic, For Treatment Of Uterine Fibroids

Culture Media, For Isolation Of Pathogenic Neisseria

FDA classification
FDA Class 2 ·Culture Media, For Isolation Of Pathogenic Neisseria