prevent the growth of, or toxin production by, pathogens is subject to the modified requirements in §117.206 for any unexposed packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens.

(a) The food additive yellow prussiate of soda (sodium ferrocyanide decahydrate; Na4Fe(CN)6·10H2O contains a minimum of 99 percent by weight of sodium ferrocyanide decahydrate. (b) The additive is used or intended for use as an anticaking agent in salt and as an adjuvant in

The food additive castor oil may be safely used in accordance with the following conditions: (a) The additive meets the specifications of the United States Pharmacopeia XX (1980). (b) The additive is used or intended for use as follows: Use and Limitations Hard candy production—As a

extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of the hexane and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section.

All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to

The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient: (a) Benzocaine 5 to 20 percent. (b) Benzyl alcohol 1 to 4 percent. (c) Dibucaine 0.25 to 1 percent. (d) Dibucaine hydrochloride 0.25 to 1 percent.

minimize or prevent the growth of, or toxin production by, pathogens is subject to the modified requirements in §507.51 for any unexposed packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens.

(a) [Reserved] (b) Tolerances. The tolerances for streptomycin are: (1) Cattle and swine. (i) Kidney: 2.0 ppm. (ii) Other edible tissues (excluding milk): 0.5 ppm. (2) Chickens.

(a) [Reserved] (b) Tolerances. The tolerances for zoalene and its metabolite 3-amino-5-nitro-o-toluamide are: (1) Chickens. (i) Liver and kidney: 6 ppm. (ii) Muscle: 3 ppm.

label and labeling shall bear in addition to the other information required by the Act: (1) The name of the additive. (2) The quantity of the additive contained therein. (3) Adequate directions for use.

is applicable, or for crossmatched blood and blood components, the name of the recipient. (c) Receipt records shall contain the name and address of the collecting facility, date received, donor or lot number assigned by the collecting facility and the date of expiration or the date of collection, whichever is applicable.

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. (b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform

to have serious adverse health consequences; (b) The device is intended to be implanted in the human body for more than 1 year; or (c) The device is intended to be used to support or sustain life and to be used outside a user facility.

(a) Identification. An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy. (b) Classification. Class I (general

(a) Identification. A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma

(a) Identification. A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease. (b) Classification. Class I (general

(a) Identification. A chromosome culture kit is a device containing the necessary ingredients (e.g., Minimum Essential Media (MEM) of McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin) used to culture tissues for diagnosis of congenital chromosome abnormalities. (b) Classification. Class I (general controls). The device

(a) Identification. A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions. (b) Classification. Class I (general controls). These devices are

) Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems.” (See §864.1(d) for the availability of this guidance document.) [69 FR 12273, Mar. 16, 2004]

(a) Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types. (b) Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket

(a) Identification. A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as immunoelectrophoresis, immunodiffusion, or chromatography. (b) Classification. Class I (general controls). The device is

(a) Identification. An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B12 to be absorbed by the body

(a) Identification. A seminal fluid (sperm) immunological test system is a device that consists of the reagents used for legal purposes to identify and differentiate animal and human semen. The test results may be used as court evidence in alleged instances of rape and other sex-related crimes. (b) Classification. Class I (general controls). The device is

(a) Identification. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere. (b) Classification. Class I (general controls). The device is exempt from the premarket notification

(a) Identification. An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere. (b) Classification. Class I (general controls). The device is exempt from

(a) Identification. A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure. (b) Classification. Class I (general controls). The device is exempt from the

(a) Identification. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction. (b) Classification. Class II (special controls) (“Class II Special Control Guidance Document for Acute

(a) Identification. A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807

, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic. (b) Classification. Class II. [51 FR 40389, Nov. 6, 1986]

(a) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures