Urine Transport Kit (excludes Hiv Testing)

Device Code: 696

Product Code(s): OHZ

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is

Device Classification Information

Device Type ID696
Device NameUrine Transport Kit (excludes Hiv Testing)
Physical StateThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
Technical MethodThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
Target AreaThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
Regulation DescriptionSpecimen Transport And Storage Container.
Regulation Medical SpecialtyPathology
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission TypeEnforcement Discretion
CFR Regulation Number864.3250 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeOHZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID696
DeviceUrine Transport Kit (excludes Hiv Testing)
Product CodeOHZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSpecimen Transport And Storage Container.
CFR Regulation Number864.3250 [🔎]
TPLC Last Update: 2019-04-02 19:38:50

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