DATA STANDARDS MANUAL


FDA Data Element Number.

CDER Data Element Number. C-DRG-00404

Version Number. 002

Data Element Name. Animal Cell-Tissue-Fluid-Biomolecule

Description. The animal cell-tissue-fluid-biomolecule data element specifies animal cells, tissues body fluids, and biomolecules, along with their scientific descriptions. It was developed in order to track drugs that have an animal origin to help ensure against contamination (e.g., BSE).

Source. CDRH Materials table which is maintained by Ken Krell.

Relationship. Animal Common Name, DRG00403.

FDA Specifications.

CDER Specifications. Animal Cell-Tissue-Fluid-Biomolecule shall consist of an alphabetic term which has a maximum length restricted to 40 characters, with the comma and hyphen being the only punctuation permissible. Codes representing these animal tissue/fluid shall consist of two digits.

FDA Approved Date.

CDER Approved Date. April 21, 1997; November 14, 1997; September 20, 2002

FDA Revised Date.

CDER Revised Date.

Data Values.

NAME DEFINITION FDA CODE
ADIPOSE LITERAL 0501055
ADRENAL LITERAL 0501056
AMNION LITERAL 0501061
BILE LITERAL 0503032
BLADDER LITERAL 0501057
BLOOD LITERAL 0501058
BONE LITERAL 0501059
BRAIN/CNS LITERAL 0501060
BREAST LITERAL 0501017
CARTILAGE LITERAL 0501018
EGG LITERAL 0501062
ELASTIC TISSUE LITERAL 0501019
EMBRYO LITERAL 0501020
ESOPHAGUS LITERAL 0501063
EYE LITERAL 0501021
FETUS LITERAL 0501022
GALLBLADDER LITERAL 0501070
GASTRIC LITERAL 0501023
GINGIVA LITERAL 0501024
GONADS (OVARIES) LITERAL 0501025
GONADS (TESTES) LITERAL 0501026
HEART LITERAL 0501027
HOOF LITERAL 0501028
HORN LITERAL 0501069
INTESTINE LITERAL 0501029
JOINT LITERAL 0501030
KIDNEY LITERAL 0501031
LIVER LITERAL 0501032
LUNG LITERAL 0501033
LYMPH LITERAL 0501034
MILK LITERAL 0503033
MUSCLE LITERAL 0501035
ORAL MUCOSA LITERAL 0501036
PANCREAS LITERAL 0501037
PARATHYROID LITERAL 0501038
PHARYNX LITERAL 0501064
PITUITARY LITERAL 0501039
PLACENTA LITERAL 0501040
PROSTATE LITERAL 0501041
PULMONARY LITERAL 0501042
RECTUM LITERAL 0501043
SERUM LITERAL 0503034
SKIN LITERAL 0501044
SPERM LITERAL 0501065
SPINAL CORD LITERAL 0501045
SPLEEN LITERAL 0501046
STOMACH LITERAL 0501047
SUBCUTANEOUS TISSUE LITERAL 0501048
SYNOVIA LITERAL 0501049
TEETH LITERAL 0501050
THYMUS LITERAL 0501066
THYROID LITERAL 0501051
TRACHEA LITERAL 0501052
UNSPECIFIED LITERAL 0501053
URINE LITERAL 0503035
VASCULAR LITERAL 0501054
WHOLE BODY LITERAL 0501068
WOOL LITERAL 0501067

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Updated 12/11/2002