... investigational radioactive pharmaceuticals, the Nuclear Regulatory Commission has compiled a list of reactor-produced isotopes for which it considers that applicants may reasonably be expected to submit adequate evidence of safety and effectiveness for use as recommended in appropriate labeling. Such use may include, among others, the uses in this tabulation:-Isotope Chemical form Use-Chromium 51. Chromate. Spleen scans. [[ Page 23 ]] Do. do. Placenta localization. Do. do. Red blood cell labeling and survival studies. Do. Labeled human serum Gastrointestinal albumin. protein loss studies. Do. do. Placenta localization. Do. Labeled red blood cells Do. Cobalt 58 or Cobalt 60 Labeled cyanocobalamin. Intestinal absorption studies. Gold 198. Colloidal. Liver scans. Do. do. Intracavitary treatment of pleural effusions and / or ascites. Do. do. Interstitial treatment of cancer. Iodine 131. Iodide. Diagnosis of thyroid functions. Do. do. Thyroid scans. Do. do. Treatment of hyperthyroidism and / or cardiac dysfunction. Do. do. Treatment of thyroid carcinoma ...

... [Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR862.1035] [Page 191] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES -Table of Contents Subpart B_Clinical Chemistry Test Systems Sec. 862.1035 Albumin test system. (a) Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. (b) Classification. Class II. ...

... [Code of Federal Regulations] [Title 21, Volume 7] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR640.80] [Page 115] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS -Table of Subpart H_Albumin (Human) Sec. 640.80 Albumin (Human). (a) Proper name and definition. The proper name of the product shall be Albumin (Human). The product is defined as a sterile solution of the albumin derived from human plasma. (b) Source material. The source material of Albumin (Human) shall be plasma recovered from Whole Blood prepared as prescribed in Sec. Sec. 640.1 through 640.5, or Source Plasma prepared as prescribed in Sec. Sec. 640.60 through 640.76. (c) Additives in source material. Source material shall not contain an additive unless it is shown that the processing method yields a final product free ...

... [Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR862.1645] [Page 209-210] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES -Table of Contents Subpart B_Clinical Chemistry Test Systems Sec. 862.1645 Urinary protein or albumin (nonquantitative) test system. (a) Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin [[ Page 210 ]] (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria. (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 Sec. 862.9. [52 FR 16122, ...

... [Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR866.5040] [Page 276] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 866_IMMUNOLOGY AND MICROBIOLOGY DEVICES -Table of Contents Subpart F_Immunological Test Systems Sec. 866.5040 Albumin immunological test system. (a) Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. (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 Sec. 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998] ...

... [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR866.5370] [Page 281] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 866_IMMUNOLOGY AND MICROBIOLOGY DEVICES -Table of Contents Subpart F_Immunological Test Systems Sec. 866.5370 Cohn fraction V immuno logical test system. (a) Identification. A Cohn fraction V immunological test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be depressed, e.g, nephrosis (disease of the kidney ), proteinuria (protein in the urine ), gastroenteropathy (disease of the stomach and small intestine ), rheumatoid arthritis, and viral hepatitis. (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 Sec. 866.9. [47 FR 50823, Nov. 9 ...

... TOXICOLOGY DEVICES -Table of Contents Subpart A_General Provisions Sec. 862.1 Scope. Subpart A_General Provisions Sec. 862.1 Scope. 862.2 Regulation of calibrators. 862.3 Effective dates of requirement for premarket approval. 862.9 Limitations of exemptions from section 510 (k) of the Federal Food, Drug, and Cosmetic Act (the act). Subpart B_Clinical Chemistry Test Systems 862.1020 Acid phosphatase (total or prostatic) test system. 862.1025 Adrenocorticotropic hormone (ACTH) test system. 862.1030 Alanine amino transferase (ALT / SGPT) test system. 862.1035 Albumin test system. 862.1040 Aldolase test system. 862.1045 Aldosterone test system. 862.1050 Alkaline phosphatase or isoenzymes test system. 862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry. 862.1060 Delta-aminolevulinic acid test system. 862.1065 Ammonia test system. 862.1070 Amylase test system. 862.1075 Androstenedione test system. 862.1080 Androsterone test system. 862.1085 Angiotensin I and renin test system. 862.1090 Angiotensin converting enzyme (A.C.E) test system. 862.1095 Ascorbic acid test system. 862.1100 Aspartate amino transferase (AST / SGOT) test system ...

... deg] C or colder. Any other bulk form of the product, exclusive of the sterile bulk solution, to be held more than 1 week prior to further processing shall be stored in clearly identified closed vessels at a temperature of 5 [deg] C or colder. Any bulk fraction to be held one week or less prior to further processing shall be stored in clearly identified closed vessels at a temperature of 5 [deg] C or colder. (e) Heat treatment. Heating of the final containers of Albumin (Human) shall begin within 24 hours after completion of filling. Heat treatment shall be conducted so that the solution is heated continuously for not less than 10, or more than 11 hours, at an attained temperature of 60 0.5 [deg] C. (f) Stabilizer. Either 0.08 0.016 millimole sodium caprylate, or 0.08 0.016 millimole sodium acetyltryptophanate and 0.08 0.016 millimole sodium caprylate per gram of protein shall be present as a stabilizer (s). Calculations of the stabilizer concentration may employ the labeled value for the protein concentration ...

... PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS -Table of Subpart H_Albumin (Human) Sec. 640.82 Tests on final product. Tests shall be performed on the final product to determine that it meets the following standards: (a) Protein concentration. Final product shall conform to one of the following concentrations: 4.0 0.25 percent; 5.0 0.30 percent; 20.0 1.2 percent; and 25.0 1.5 percent solution of protein. (b) Protein composition. At least 96 percent of the total protein in the final product shall be albumin, as determined by a method that has been approved for each manufacturer by the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. (c) pH. The pH shall be 6.9 0.5 when measured in a solution of the final [[ Page 116 ]] product diluted to a concentration of 1 percent protein with 0.15 molar sodium chloride. (d) Sodium concentration. The sodium concentration of the final product shall be 130 to 160 milliequivalents per liter. (e) Potassium concentration. The potassium concentration of the final ...

... that cream cheese, neufchatel cheese, cottage cheese, creamed cottage cheese, cook cheese, hard grating cheese, semisoft part-skim cheese, and part-skim spiced cheese are not used, alone or in combination with each other, as the cheese ingredient. (d) The optional dairy ingredients referred to in paragraph (a) of this section are cream, milk, skim milk, buttermilk, cheese whey, any of the foregoing from which part of the water has been removed, anhydrous milkfat, dehydrated cream, albumin from cheese whey, and skim milk cheese for manufacturing. (e) The emulsifying agents prescribed in paragraph (a) of this section are one or any mixture of two or more of the following: Monosodium phosphate, disodium phosphate, dipotassium phosphate, trisodium phosphate, sodium metaphosphate (sodium hexa meta phos phate ), sodium acid pyro phos phate, tetra sodium pyro phos phate, sodium aluminum phosphate, sodium citrate, potassium citrate, calcium citrate, sodium tartrate, and sodium potassium tartrate, in such quantity that the weight of the ...