Test, Morphine, Employment And Insurance Testing, Exempt

Device Code: 6268

Product Code(s): PVG

Definition: The Morphine Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Morphine For Employment And Insurance Testing. FDA Has Exempted These Devices From The Premarket Notification Requirement By Publishing In The Federal Register Of July 1

Device Classification Information

Device Type ID6268
Device NameTest, Morphine, Employment And Insurance Testing, Exempt
Physical StateIn Vitro Diagnostic Device
Technical MethodImmunoassay
Target AreaIn Vitro Specimen
Regulation DescriptionMorphine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.3640 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePVG
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6268
DeviceTest, Morphine, Employment And Insurance Testing, Exempt
Product CodePVG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMorphine Test System.
CFR Regulation Number862.3640 [🔎]
TPLC Last Update: 2019-04-02 21:19:38

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