A-A-50978
28 August 1985
COMMERCIAL ITEM DESCRIPTION
TUBE, BIOLOGICAL CULTURE SAMPLING,
Pledget Style, with Transport Media, Plastic
This Commercial Item Description covers a sterile, pledget style, biological culture sampling tube, suitable for collecting and holding biological cultures moist an viable for 72 hours.
Salient characteristics:
Shall be an assembled sterile biological culture sampling tube suitable for collecting and holding biological cultures, such as pseudomonas aeruginosa ATCC No. 15422 and Group a Streptococcus ATCC No. 79 58, moist and viable for 72 hours.
As a minimum shall consist of a plastic tube, snug-fitting closure cap, applicator swab, absorbent fabric plug (pledget), and transport media. Shall be supplied sealed in a peel-open type envelope suitable for maintaining sterility until manually opened. The envelope shall not be resealable after opening.
The method and efficacy of sterilization of the biological tube and inside surfaces of the envelope shall be acceptable to the Food and Drug Administration (FDA).
The tube shall be fabricated of transparent or translucent semi-rigid plastic. The distal end shall be closed to preclude leakage of transport media. The opposite end shall be open, and shall be supplied with a snug fitting and readily removable closure cap.
The applicator stick shall be wood or plastic and cylindrical in shape with nominal dimensions (inches) of 3/32 diameter x 5 long. The distal end of the stick shall e covered with a swab tip made of cotton, or polyester. A suitable adhesive shall be used to secure the swab tip to the stick.
The transport media shall be Modified Stuarts a media or Amies media without charcoal.
The Modified Stuarts transport media shall be supplied in a crushable glass ampule. The ampule shall be located in the distal portion of the tube below the absorbent fabric plug (pledget) that shall separate the ampule from the applicator swab.
The Amies swab transport media shall be contained in a sealed chamber located at the distal end of the tube, with the absorbent fabric plug (pledget) positioned to separate the sealed chamber from the applicator swab.
The method of moistening the swab tip shall be included in the manufacturer’s instructions.
The volume of transport media shall be sufficient to cover and moisten all surfaces of the swab tip, after passing through the absorbent fabric plug (pledget), and keep any collected live cultures located on an sector (surface) of the swab tip viable for 72 hours.
When the swab tip is moistened, by following manufacturer’s instructions, the released transport media shall completely cover and completely moisten the swab tip without exhibiting the following (see Quality Assurance Provisions):
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