A-A-54612
Sensitivity test. Shall be capable of detecting between 1 to 2 I.U. Human Chorionic Gonadotropin (HCG) per ml when tested as specified below.
The following method shall be employed in the detection of sensitivity of the pregnancy kit. Prepare, using a 0.9 percent NaCl/0.1 percent Bovine Serum Albumin solvent, dilutions of HCG to contain 0, 500, 1000, 1500, 2000, 2500 and 3000 I.U. HCG per liter. Agglutination must be readily discernible with the standards made to contain 0 and 500 I.U. HCG per liter. Agglutination may be present with 1000 I.U. per liter and Agglutination may be present with 1500 I.U. HCG per liter. The standard containing 2000 I.U. HCG per liter will inhibit the agglutination so that at the termination of the two minute rocking period only a very slight agglutination (if any) is visible. The standards containing greater than 2000 I.U. HCG per liter must show macroscopic inhibition of agglutination.
Reaction test. Shall be capable of detecting a positive response (no agglutination) and negative response (agglutination) when tested as specified below.
The test kit shall be tested against ten (10) known positive and ten (10) known negative pregnant female urines (Controls) using the method specified in the labeling. Positive responses (no agglutination) shall result when the positive control is used and negative responses (macroagglutination, clumping) shall result when the negative control is used. A negative test shall be visible within two minutes and a positive test shall occur at the end of two minutes.
Workmanship. The product shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Each (EA). One test kit, as specified, constitutes one unit.
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