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Protein, Complement, Antigen, Antiserum, Control

Page Type
Product Code
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
866.4100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 866.4100 Complement reagent

§ 866.4100 Complement reagent.

(a) Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]

Protein, Complement, Antigen, Antiserum, Control

Page Type
Product Code
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
866.4100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 866.4100 Complement reagent

§ 866.4100 Complement reagent.

(a) Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]