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Blood/Plasma Collection Device For Dna Testing

Page Type
Product Code
Definition
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Physical State
Blood collection device
Technical Method
The blood is drawn in the tube to be transported to the laboratory for clinical DNA testing.
Target Area
Whole blood/ plasma for in vitro diagnostics
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.

Blood/Plasma Collection Device For Dna Testing

Page Type
Product Code
Definition
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Physical State
Blood collection device
Technical Method
The blood is drawn in the tube to be transported to the laboratory for clinical DNA testing.
Target Area
Whole blood/ plasma for in vitro diagnostics
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.