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Media, Culture, Ex Vivo, Tissue And Cell

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5885
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications

§ 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.

(a) Identification. Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.

(b) Classification. Class II (special controls): FDA guidance document, “Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Processing Applications; Final Guidance for Industry and FDA Reviewers.”

[66 FR 27025, May 16, 2001]

Media, Culture, Ex Vivo, Tissue And Cell

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5885
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications

§ 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.

(a) Identification. Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.

(b) Classification. Class II (special controls): FDA guidance document, “Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Processing Applications; Final Guidance for Industry and FDA Reviewers.”

[66 FR 27025, May 16, 2001]