Pulse-Generator, Program Module

FDA classification

FDA Class 3 ·Pulse-Generator, Program Module

Finger Cot

FDA classification

FDA Class 1 ·Finger Cot

Ecarin Clotting Time

FDA classification

Ecarin Clotting Time

Timer, Clot, Automated

FDA classification

FDA Class 2 ·Timer, Clot, Automated

Test, Ecarin Clotting Time (Ect)

FDA classification

Test, Ecarin Clotting Time (Ect)

Activated Whole Blood Clotting Time

FDA classification

FDA Class 2 ·Activated Whole Blood Clotting Time

Kit, Western Blot, Hiv-1

FDA classification

FDA Not Classified ·Kit, Western Blot, Hiv-1

Aid, Vision Image Intensification

FDA classification

FDA Class 1 ·Aid, Vision Image Intensification

Antigen, B. Parapertussis

FDA classification

FDA Class 1 ·Antigen, B. Parapertussis

Antithrombin Iii, Two Stage Clotting Time Assay

FDA classification

FDA Class 2 ·Antithrombin Iii, Two Stage Clotting Time Assay

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, Approved By Nys Clep

FDA classification

FDA Not Classified ·Ldt, Approved By Nys Clep

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

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification

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

Drape, Pure Latex Sheet, With Self-Retaining Finger Cot

FDA classification

FDA Class 2 ·Drape, Pure Latex Sheet, With Self-Retaining Finger Cot

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

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

Catheter, Thrombus Retriever

FDA classification

FDA Class 2 ·Catheter, Thrombus Retriever

Clamp, Dialysis Arm

FDA classification

FDA Class 1 ·Clamp, Dialysis Arm

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