Product Directory — Diagnostics, Devices & Equipment

 

• More Sensitive – Detects 20 mIU/mL hCG or greater in both urine and serum specimens

• QuPID® Plus E.R. Detects 10 mIU/mL hCG in serum specimens

• Faster – Positive results may be seen in as little as 10 seconds

• Accuracy: >99%, Specificity: >99%

• Improved Readability – Quick clearing background ensures easy-to-read results even with low-level specimens

• Built-in Positive and Negative Procedural Controls – Ensure proper reagent function and correct testing procedure

• Color-coded devices make it easy to differentiate between urine and serum/urine tests

• Simplified test instructions printed on each pouch

• Convenient to use – Specimen dropper packaged with each test device

• Room temperature storage

• CLIA Status: Waived (Urine specimens)

• Long Shelf-life

 

• QuPID Product Information

STANBIO LABORATORY 1261 North Main Street | | Boerne | TX | Stanbio Laboratory is committed to manufacture and market a complete line of high quality clinical diagnostic products with an unmatched level of service and support.

Enhanced Sensitivity Excellent

detection of low-level positives, offering

superior sensitivity when compared to the

leading competition.

Easy-to-Use CLIA waived, requires

minimal training.

Complete The kit includes everything

you need – cassettes, reagents, controls,

swabs, and quick reference guide.

Fast Results in five minutes!

Improved Readability Clearly visible

results window makes it easy to interpret

 

EZ-Well™ Strep a

Ref No. Size

6100-025 25 Test

• EZ Well Information

STANBIO LABORATORY 1261 North Main Street | | Boerne | TX | Stanbio Laboratory is committed to manufacture and market a complete line of high quality clinical diagnostic products with an unmatched level of service and support.

QuStick™ eliminates waste with room temperature storage and a two-year shelf life from date of manufacture. You get results in five minutes and, QuStick™ Strep A consistently outperforms the leading brand.

Each kit includes:
• Individually pouched test strips
• Reagent A and Reagent B
• Positive and negative external controls
• Dacron throat swabs
• Extraction tubes
• Package insert
• Handy pictorial quick guide showing step-by-step procedure.

• QuStick Product Information

STANBIO LABORATORY 1261 North Main Street | | Boerne | TX | Stanbio Laboratory is committed to manufacture and market a complete line of high quality clinical diagnostic products with an unmatched level of service and support.

With the addition of alpha, Stanbio’s family of one-step pregnancy tests offers greater flexibility and sensitivity to meet your needs.

• Product Information

STANBIO LABORATORY 1261 North Main Street | | Boerne | TX | Stanbio Laboratory is committed to manufacture and market a complete line of high quality clinical diagnostic products with an unmatched level of service and support.

 The BTA stat® test is a point of care technology for the early detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine.  It is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen in voided urine.  The specificity of the BTA stat® test was 93 - 95% in patients with non-genitourinary diseases and cancers and healthy individuals tested as part of a multi-center study.  The test has a sensitivity that is considerably higher than voided urine cytology, enabling detection of recurrent early stage and grade cancers that cytology often misses.  Requiring three drops of urine, the result is delivered in only five minutes.  The appearance of a line in the patient window indicates a positive result.  The BTA stat® test requires one voided urine sample with no sample preparation.  The BTA stat® test is CLIA waived and also available for prescription home use.

POLYMEDCO, INC. 510 Furnace Dock Road | | Cortlandt Manor | NY | Polymedco Inc. is a leading manufacturer, marketer, and distributer in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits and devices that are specialized in chemistry, hematology and cancer.

Primary applications for this product include Occupational Exposures, Labor & Delivery and Emergency Departments. The Reveal tests have consistently ranked as a leading choice in rapid HIV tests for US hospitals over the past several years.

Key advancements in the Reveal® G3 product include the addition of MedMira’s InstantGold™ Cap which replaces the colorimetric detection agent used to visualize results on the test cartridge. This advancement eliminates the need for reconstitution and refrigeration of the colorimetric detection agent, improving the product’s overall ease-of-use. MedMira now offers Reveal® G3 in a box of 30, a new size format designed to maximize efficiency of all components included in the test package.

MEDMIRA 155 Chain Lake Drive | | Halifax | NS | We develop and manufacture quality rapid diagnostics that help healthcare providers, public health agencies, and individuals prevent and control the spread of infectious diseases like HIV and Hepatitis, two of the top 10 causes of infectious disease deaths worldwide.

CLIA-waived for rapid detection of acute conjunctivitis

AdenoPlus is the only CLIA-waived, point-of-care test for adenoviral conjunctivitis, commonly called pink eye.

Rule In/Rule Out

• Rapid: results in 10 minutes
• Accurate: high sensitivity and specificity
• Easy: performed by any healthcare professional
• Inexpensive: no additional equipment required

Clinical Benefits

• Help reduce misdiagnosis and unnecessary antibiotics
• Professional clinical guideline recommendations: AAO Preferred Practice Patterns, AAP Red Book, PIER, Uptodate, and the Choosing Wisely® program

• AdenoPlus Clinical Guidelines
• AdenoPlus Information Sheet
• AdenoPlus One Pager
• AdenoPlus Package Insert
• AdenoPlus Physician Resource Guide
• AdenoPlus Sell Sheet
• Conjunctivitis Coding Guidelines

RPS INC. 7227 Delainey Court | | Sarasota | FL | RPS, the Next Generation CRO, provides comprehensive global Phase I-IV clinical development solutions to the Pharmaceutical, Biotechnology, Medical Device and Diagnostic industries. By combining our highly experienced clinical research operations infrastructure with the industrys largest resourcing engines, RPS is uniquely positioned to offer our Customers a broad spectrum of outsourcing solutions.

Status BTA

A Rapid Test For the Qualitative Detection of Bladder Tumor Associated Antigen in Human Urine

• CLIA Waived
• Uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine
• Simple procedure requires only adding urine to test device
• Accurate test results with superior sensitivity and specificity
• Detects early stage recurrence cancer that cytology may miss
• Results available in 5 minutes
• Adjunct test to cystoscopy

Lifesign 85 Orchard Rd | | Skillman | NJ | A Rapid Test For the Qualitative Detection of Bladder Tumor Associated Antigen in Human Urine

An in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens.

• Rapid diagnosis for early treatment
• 22 test kit (Includes two free tests for QC)
• Innovative flip test design
• Easy-to-read cassette
• Positive results in 10 minutes
• Pre-measured developer solution capsule for increased accuracy and ease of use
• Flock nasal swabs included for better specimen collection
• Detects H1N1 (Swine Flu)

Lifesign 85 Orchard Rd | | Skillman | NJ | A Rapid Test For the Qualitative Detection of Bladder Tumor Associated Antigen in Human Urine

For The Qualitative Detection Of Infectious Mononucleosis Heterophile Antibodies In Whole Blood, Serum Or Plasma.

• FDA cleared with no age restrictions
• CLIA WAIVED for whole blood
• Single reagent procedure provides results in 3-8 minutes
• Fingerstick whole blood convenience
• Superior 99.9% sensitivity for earlier IM detection, specificity of 98.8%
• Multiple kit sizes available, ideal for any practice
• External QC negative and positive controls included (item # 68364 & 84M30)
• New plastic sample transfer pipettes

Lifesign 85 Orchard Rd | | Skillman | NJ | A Rapid Test For the Qualitative Detection of Bladder Tumor Associated Antigen in Human Urine