173 results · 39ms · Sources: EU EUDAMED, US FDA

Cryogenic Cord Blood Storage Container

FDA classification
FDA Class 2 ·Cryogenic Cord Blood Storage Container

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Lead, Atomic Absorption

FDA classification
FDA Class 2 ·Lead, Atomic Absorption

Antisera, Neutralization, Poliovirus 1-3

FDA classification
FDA Class 1 ·Antisera, Neutralization, Poliovirus 1-3

Ldt, Approved By Nys Clep

FDA classification
FDA Not Classified ·Ldt, Approved By Nys Clep

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification
FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Laparoscope, General & Plastic Surgery

FDA classification
FDA Class 2 ·Laparoscope, General & Plastic Surgery

Arthroscope

FDA classification
FDA Class 2 ·Arthroscope

Electrosurgical, Cutting & Coagulation & Accessories

FDA classification
FDA Class 2 ·Electrosurgical, Cutting & Coagulation & Accessories

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification
FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Hemodialyzer, High Cut-Off

FDA classification
Hemodialyzer, High Cut-Off

Osmolality Of Tears

FDA classification
FDA Class 1 ·Osmolality Of Tears

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA classification
FDA Class 2 ·Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA classification
FDA Class 2 ·System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

FDA classification
FDA Class 1 ·Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

FDA classification
FDA Not Classified ·Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

Washer Of Body Waste Receptacles

FDA classification
FDA Class 1 ·Washer Of Body Waste Receptacles

Radioimmunoassay, C-Peptides Of Proinsulin

FDA classification
FDA Class 1 ·Radioimmunoassay, C-Peptides Of Proinsulin

Rhinoanemometer (Measurement Of Nasal Decongestion)

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