Urine Collection Kit (excludes Hiv Testing)

Device Code: 699

Product Code(s): OIE

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 ID699
Device NameUrine Collection 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 CodeOIE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID699
DeviceUrine Collection Kit (excludes Hiv Testing)
Product CodeOIE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSpecimen Transport And Storage Container.
CFR Regulation Number864.3250 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Gen-Probe Inc
III Jun-14-2014
TPLC Last Update: 2019-04-02 19:38:52

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