Handylab, Inc.

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Contact: Martha Rumford
Web: http://www.handylab.com
E-Mail:
Address: 5230 South State Road, Ann Arbor, Michigan 48108, USA
Phone: +1-(734)-663-4719/225 | Fax: +1-(734)-663-7437 | Map/Directions >>

Profile: Handylab, Inc. specializes in the production of diagnostic devices. Our products include BD GeneOhm™ and BD Max™ system. The BD GeneOhm™Cdiff assay is a diagnostic test for the rapid detection of C.difficile toxin B gene in human liquid or soft stool specimens from patients suspected of having clostridium difficile infection. This test is based on real-time PCR and is intended for use as an aid in diagnosis of CDI. The BD GeneOhm™ MRSA assay is used for the direct detection of methicillin-resistant staphylococcus aureus from a nasal specimen. The Jaguar line of reagents and consumables are designed to be used for nucleic acid extraction and as components of laboratory developed tests. These reagents and consumables are compatible with both the Jaguar and BD Max branded instruments.

The company is ISO 13485 certified.

6 Products/Services (Click for related suppliers)

• Clinical Sample Concentrator (FDA Code: JJH / 862.2310)

A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.

• Diagnostic Aids

• Direct Specimen Test of Group B Streptococcus Nucleic Acid Amplification Assay System (FDA Code: NJR / 866.3740)

• General Purpose Reagent (FDA Code: LDT)

• Micro Chemistry Analyzer (FDA Code: JJF / 862.2170)

A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

• Real Time Nucleic Acid Amplification System (FDA Code: OOI / 862.2570)