Radioimmunoassay, Parathyroid Hormone

Device Code: 276

Product Code(s): CEW

Device Classification Information

Device Type ID276
Device NameRadioimmunoassay, Parathyroid Hormone
Regulation DescriptionParathyroid Hormone Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1545 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCEW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID276
DeviceRadioimmunoassay, Parathyroid Hormone
Product CodeCEW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionParathyroid Hormone Test System.
CFR Regulation Number862.1545 [🔎]
Premarket Reviews
ManufacturerDecision
DIASORIN
 
SUBSTANTIALLY EQUIVALENT
 1
DIASORIN S.P.A
 
SUBSTANTIALLY EQUIVALENT
 1
SIEMENS
 
SUBSTANTIALLY EQUIVALENT
 2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
 
SUBSTANTIALLY EQUIVALENT
 2
Device Problems
High Test Results
 59
Adverse Event Without Identified Device Or Use Problem
 42
Device Ingredient Or Reagent Problem
 24
Low Test Results
 22
Mechanical Problem
 16
Incorrect Or Inadequate Test Results
 7
No Apparent Adverse Event
 6
Tube
 3
Device Issue
 2
Output Problem
 2
Probe
 2
Incorrect, Inadequate Or Imprecise Result Or Readings
 1
Device Handling Problem
 1
Appropriate Term/Code Not Available
 1
Incorrect Measurement
 1
Non Reproducible Results
 1
Valve
 1
False Positive Result
 1
Total Device Problems 192
Recalls
Manufacturer Recall Class Date Posted
1
Diagnostic Hybrids, Inc.
 III Apr-25-2018
2
ORTHO-CLINICAL DIAGNOSTICS
 II Dec-23-2016
3
Siemens Healthcare Diagnostics, Inc.
 II Jan-09-2017
TPLC Last Update: 2019-04-02 19:32:02
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