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Manual Blood Grouping And Antibody Test Systems

Page Type
Product Code
Definition
A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Physical State
Solid
Technical Method
Manual
Target Area
IVD
Regulation Medical Specialty
Hematology
Review Panel
Hematology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
864.9175
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 864.9175 Automated blood grouping and antibody test system

§ 864.9175 Automated blood grouping and antibody test system.

(a) Identification. An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

(b) Classification. Class II (performance standards).

[45 FR 60641, Sept. 12, 1980]

Manual Blood Grouping And Antibody Test Systems

Page Type
Product Code
Definition
A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Physical State
Solid
Technical Method
Manual
Target Area
IVD
Regulation Medical Specialty
Hematology
Review Panel
Hematology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
864.9175
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 864.9175 Automated blood grouping and antibody test system

§ 864.9175 Automated blood grouping and antibody test system.

(a) Identification. An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

(b) Classification. Class II (performance standards).

[45 FR 60641, Sept. 12, 1980]