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Media, Potentiating For In Vitro Diagnostic Use

Page Type
Product Code
Regulation Medical Specialty
Hematology
Review Panel
Hematology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
864.9600
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 864.9600 Potentiating media for in vitro diagnostic use

§ 864.9600 Potentiating media for in vitro diagnostic use.

(a) Identification. Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]

Media, Potentiating For In Vitro Diagnostic Use

Page Type
Product Code
Regulation Medical Specialty
Hematology
Review Panel
Hematology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
864.9600
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 864.9600 Potentiating media for in vitro diagnostic use

§ 864.9600 Potentiating media for in vitro diagnostic use.

(a) Identification. Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]