Radioimmunoassay, Angiotensin I And Renin

Device Code: 328

Product Code(s): CIB

Device Classification Information

Device Type ID328
Device NameRadioimmunoassay, Angiotensin I And Renin
Regulation DescriptionAngiotensin I And Renin 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 Number862.1085 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCIB
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 ID328
DeviceRadioimmunoassay, Angiotensin I And Renin
Product CodeCIB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAngiotensin I And Renin Test System.
CFR Regulation Number862.1085 [🔎]
TPLC Last Update: 2019-04-02 19:32:51

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