J&S Medical Associates, Inc.

35 Tripp Street, Bldg. 1
Framingham,  MA  01702

Email: sales@jsmed.com

www.jsmed.com

TEST KIT REQUIREMENTS

CONTROLS

Fecal Occult Blood Control Kit

FOB Controls

Urine Control, General

HGB Controls

Whole Blood Hemoglobin Control

Urinalysis Controls

CORPORATE DESCRIPTION:

J & S Medical Associates, Inc. is a 33 year old diagnostic manufacturing company specializing in products for the point if care market.  J & S offers specialty controls for occult blood, hemoglobin testing, urinalysis and hematology.  J & S also offers rapid tests for HCG and Drugs of Abuse.

TEST KIT REQUIREMENTS:

FEC5000-1: Fecal Occult Blood Control Kit, 2 x 1

• CLIA Classification – Waived

• CPT Code - 82270

URN5005: Urine Control, General, 4 x 25mL, A/N

• CLIA Classification – Waived

• CPT Code - 81002

MSI HEMA-TROL™ Whole Blood Hemoglobin Control

• HYC84666                  6 x 3ml Low Level

• HYC84667                  6 x 3ml Normal Level

• HYC84668                  6 x 3ml High Level

• HYC84669                  6 x 3ml Set (2 each: Low, Normal, High)

• HYC84665                  3 x 3ml Set (1 each: Low, Normal, High)
  

• CLIA Classification – Waived

• CPT Code - 85018QW

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FOB Controls

Test Method: J & S Fecal Hemoglobin Controls are synthetic mixtures with the consistency and appearance of normal human feces.  They are intended for use in monitoring quality control of qualitative fecal hemoglobin test by the clinical laboratory.

• Sample Volume: Use same amount as a  patient sample.

• Time to Result: Refer to test kit manufacturer’s package insert.

• Units in which Test is reported:  Refer to test kit manufacturer’s package insert.

HGB Controls

Test Method: Accepted laboratory procedure requires that stable reference controls be periodically used to monitor accuracy and precision. HEMA-Trol HGB Control may be used as one would use whole blood in obtaining the stated parameters for HemoCue photometers.

• Stability: 24 months from DOM / Open vial: 60days at 2-8°C or 30 days at RT

• Sample Volume: Use same amount as a  patient sample.

• Time to Result: Refer to test kit manufacturer’s package insert.

• Units in which Test is Reported: Refer to test kit manufacturer’s package insert.

Urinalysis Controls

Test Method: The J&S Medical Associates SENTRY Urine Dipstick Controls are supplied in two levels, 2 x 25 mL each level per box. They are ready to use liquid controls that DO NOT require any dilution or reconstitution. The two Sentry controls are prepared with human and animal proteins and with various chemical additives.  These chemicals interact with the dipstick reactant pads to produce specific color changes that mimic actual normal and/or abnormal urine samples. Level 1 is an Abnormal control, and Level 2 is a Normal control. Preservatives have been added to inhibit microbial growth.

• Stability:  18 months when stored at 2-8°C or 60 days when stored at Room Temp

• Sample Volume: Use same amount as a  patient sample.

• Time to Result: Refer to test kit manufacturer’s package insert.

• Units in which Test is Reported: Refer to test kit manufacturer’s package insert.

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Last updated:  07/17/2003
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© 2003 Medical Automation Systems, Inc.