Diagnostic X-Ray Equipment (Noncertified)

FDA classification

FDA Not Classified ·Diagnostic X-Ray Equipment (Noncertified)

Industrial X-Ray

FDA classification

FDA Not Classified ·Industrial X-Ray

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

Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

FDA classification

FDA Not Classified ·Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System

FDA classification

FDA Not Classified ·For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System

Research Use Only/Clinical Chemistry Devices

FDA classification

FDA Not Classified ·Research Use Only/Clinical Chemistry Devices

For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System

FDA classification

FDA Not Classified ·For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System

Investigational Use Only - Clinical Chemistry

FDA classification

FDA Not Classified ·Investigational Use Only - Clinical Chemistry

Ldt, Approved By Nys Clep

FDA classification

FDA Not Classified ·Ldt, Approved By Nys Clep

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification

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

Test, Nr2 Antibody

FDA classification

FDA Not Classified ·Test, Nr2 Antibody

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

Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule