§640.5. Testing the blood. — Inbound Citations

(b) The source material of Immune Globulin (Human) shall be plasma recovered from Whole Blood prepared as prescribed in §§ 640.1 through 640.5, or Source Plasma prepared as prescribed in §§ 640.60 through 640.76.

(b) The source material of Albumin (Human) shall be plasma recovered from Whole Blood prepared as prescribed in §§ 640.1 through 640.5, or Source Plasma prepared as prescribed in §§ 640.60 through 640.76.

(b) The source material of Plasma Protein Fraction (Human) shall be plasma recovered from Whole Blood prepared as prescribed in §§ 640.1 through 640.5, or Source Plasma prepared as prescribed in §§ 640.60 through 640.76.

(2) Results of any tests prescribed under §§ 610.40 and 640.5(b) or (c) of this chapter completed before shipment.

Blood from which Red Blood Cells are prepared shall be tested as prescribed in § 610.40 of this chapter and § 640.5 (b) and (c).

(a) Blood from which plasma is separated for the preparation of Platelets shall be tested as prescribed in § 610.40 of this chapter and § 640.5 (b) and (c).

(a) Blood from which plasma is separated shall be tested as prescribed in § 610.40 of this chapter and § 640.5 (b) and (c).

(a) Blood from which plasma is separated for the preparation of Cryoprecipitated AHF shall be tested as prescribed in § 610.40 of this chapter and § 640.5 (b) and (c).

(2) Results of any tests prescribed under §§ 610.40 and 640.5(b) or (c) of this chapter completed before shipment.

Blood from which Red Blood Cells are prepared shall be tested as prescribed in § 610.40 of this chapter and § 640.5 (b) and (c).

(a) Blood from which plasma is separated for the preparation of Platelets shall be tested as prescribed in § 610.40 of this chapter and § 640.5 (b) and (c).

(a) Blood from which plasma is separated shall be tested as prescribed in § 610.40 of this chapter and § 640.5 (b) and (c).

(a) Blood from which plasma is separated for the preparation of Cryoprecipitated AHF shall be tested as prescribed in § 610.40 of this chapter and § 640.5 (b) and (c).

(4) The blood is held for observation until a significant inspection consistent with the requirements of § 640.5(e) can be made.