Test, Benzodiazepine, Employment And Insurance Testing, Exempt

Device Code: 6262

Product Code(s): PUZ

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

Device Classification Information

Device Type ID6262
Device NameTest, Benzodiazepine, Employment And Insurance Testing, Exempt
Physical StateIn Vitro Diagnostic Device
Technical MethodImmunoassay
Target AreaIn Vitro Specimen
Regulation DescriptionBenzodiazepine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.3170 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePUZ
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6262
DeviceTest, Benzodiazepine, Employment And Insurance Testing, Exempt
Product CodePUZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionBenzodiazepine Test System.
CFR Regulation Number862.3170 [🔎]
Device Problems
Fail-Safe Design Failure
1
Nonstandard Device
1
Device Slipped
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 21:19:33

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