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Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Page Type
Product Code
Definition
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Physical State
Specimen collection device, which may include an absorbent oral fluid collection pad and/or a specimen storage container for collection, preservation and transport.
Technical Method
Collects oral fluid and stabilizes it for transport or storage.
Target Area
clinical samples (oral fluid)
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1675
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1675 Blood specimen collection device

§ 862.1675 Blood specimen collection device.

(a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

(b) Classification. Class II.

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Page Type
Product Code
Definition
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Physical State
Specimen collection device, which may include an absorbent oral fluid collection pad and/or a specimen storage container for collection, preservation and transport.
Technical Method
Collects oral fluid and stabilizes it for transport or storage.
Target Area
clinical samples (oral fluid)
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1675
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1675 Blood specimen collection device

§ 862.1675 Blood specimen collection device.

(a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

(b) Classification. Class II.