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

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EZCHEK/HBA BLOOD COLLECTION KIT

FDA 510(k)
FDA Class 2 ·Hematology

RADIAS MONOCLONAL HBA 1C ASSAY

FDA 510(k)
FDA Class 2 ·Hematology

GLYCOSAL II HBA 1C TEST

FDA 510(k)
FDA Class 2 ·Hematology

HBA SPERM-HYALURONAN BINDING ASSAY

FDA 510(k)
FDA Class 2 ·Hematology

SICKLE HEMOGLOBIN (HBA/S) CONTROL SET

FDA 510(k)
FDA Class 2 ·Hematology

INFINITY HBA KIT, MODELS 537-A, 537-B

FDA 510(k)
FDA Class 2 ·Hematology

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Neurosurgical Paddie

FDA classification
FDA Class 2 ·Neurosurgical Paddie

ENIT ABA THYROXINE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AUTO-ALBUMIN REAG FOR ABBOTT ABA-100

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A

FDA 510(k)
FDA Class 2 ·Radiology

Monitor, Air Embolism, Ultrasonic

FDA classification
FDA Class 2 ·Monitor, Air Embolism, Ultrasonic

Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

Kit, Typing, Hla-Dqb

FDA classification
FDA Class 2 ·Kit, Typing, Hla-Dqb

Antigen, Ha (Including Ha Control), Rubella

FDA classification
FDA Class 2 ·Antigen, Ha (Including Ha Control), Rubella

ß-Glucocerebrosidase (Gba) Newborn Screening Test System

FDA classification
FDA Class 2 ·ß-Glucocerebrosidase (Gba) Newborn Screening Test System

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification
FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Antigens, Ha, Treponema Pallidum

FDA classification
FDA Class 2 ·Antigens, Ha, Treponema Pallidum

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

FDA classification
FDA Class 2 ·Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.