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Thermo Biostar, Inc.
331 South 104^th Street
Louisville, CO 80027
1-800-637-3717 ext 1
info@thermobiostar.com

www.thermobiostar.com

CORPORATE DESCRIPTION:

Headquartered in Louisville, Colorado, Thermo BioStar develops, manufactures, and markets rapid diagnostic tests for infectious diseases in the U.S. and select international markets. The company’s patented OIA^® (Optical ImmunoAssay) technology provides tests with extremely high sensitivity and specificity. They are the most effective rapid testing technology in the world providing culture equivalence or better in minutes. Each OIA test is configured to capture a unique analyte target and amplify its presence by creating a visible blue spot. OIA utilizes a silicon chip surface to reduce background, optimize signal to noise, and provide lab quality results in minutes.

Thermo Biostar, Inc. is a division of Thermo Electron Corporation, a global leader in providing technology-based instruments, components, and systems that offer total solutions for markets ranging from life sciences to telecommunications to food, drug, and beverage production.

For product information, click on the appropriate link below (for MSDS information on any product, contact ThermoBioStar for specific information):

Test Kits				Products
MAX OIA	Acceava Group A Strep	Strep B OIA	Acceava hCG Basic	PocketChem UA
FLU OIA	Cd TOX A OIA	Acceava hCG Combo	ImmunoSTAT! Rotavirus
RSV OIA	Chlamydia OIA	Acceava hCG MidStream
PocketChem UA and Aution Sticks 10TA		Acceava Mononucleosis
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MAX OIA
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate	Strep A	87880	-----	87880 (moderate)	Optical Immunoassay	30-60 μl	5 minutes	Qualitative Positive/ Negative
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FLU OIA
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate	Influenza A and B	87804	-----	-----	Optical Immuno assay	30-60 μl	15 minutes	Qualitative Positive/ Negative
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RSV OIA
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate	Respiratory Syncytial Virus	87420	-----	-----	Optical Immunoassay	30-60 μl	15 minutes	Qualitative Positive/ Negative
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Acceava Mononucleosis
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate/ Waived	Mononucleosis	86308 (moderate)	-----	-----	Enzyme Immunoassay	30-60 μl	5 minutes	Qualitative Positive/ Negative
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Acceava Group A Strep
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Waived	Strep A	-----	-----	-----	Enzyme Immunoassay	30-60 μl	5 minutes	Qualitative Positive/ Negative
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Cd TOX A OIA
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate	Clostridium difficile A	87803	-----	-----	Optical Immunoassay	30-60 μl	10 minutes	Qualitative Positive/ Negative
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Chlamydia OIA
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate	Chlamydia	87810	-----	-----	Optical Immunoassay	30-60 μl	20 minutes	Qualitative Positive/ Negative
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Strep B OIA
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate	Group B Strep	87802	-----	-----	Optical Immunoassay	250 μl	28 minutes	Qualitative Positive/ Negative
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Acceava hCG Combo
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate/ Waived	Pregnancy	84703	QW	-----	Enzyme Immunoassay	135 μl	4 min. for Urine; 5-7 min. for Serum (depending on sensitivity levels)	Qualitative Positive/ Negative
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Acceava hCG MidStream
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Waived	Pregnancy	81025	-----	-----	Enzyme Immunoassay	30-60 μl	5 minutes	Qualitative Positive/ Negative
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Acceava hCG Basic
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Waived	Pregnancy	81025	-----	-----	Enzyme Immunoassay	30-60 μl	5 minutes	Qualitative Positive/ Negative
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ImmunoSTAT! Rotavirus
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Moderate	Rotavirus	87425	-----	-----	Enzyme Immunoassay	25 μl	10 minutes	Qualitative Positive/ Negative
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PocketChem UA and Aution Sticks 10TA
	CLIA Class.	Analytes performed	CPT Code for each analyte	86308 QW (waived)	87880 QW (waived)	Test method	Sample volume	Result time	Units the test is reported
	Pending	Blood, Glucose, Ketones, Bilirubin, Urobilinogen, Proteins, pH, Leukocytes, Specific Gravity, Nitrites	81001, 81003	-----	-----	Enzyme Immunoassay	25 μl	1 minute	Semi- quantitative Normal/ Abnormal
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PocketChem UA
	Test Menu Blood, Glucose, Ketones, Bilirubin, Urobilinogen, Proteins, pH, Leukocytes, Specific Gravity, Nitrites Features Lab – quality results urinalysis on the go Palm-sized, automated urine analyzer eliminates visual interpretation and medical transcription errors Unique 11th pad on the strip measures color and corrects Specific Gravity on every run. Measures ambient temperature and corrects for pH. Print if and when you want to—results are immediately available on screen Electronic interpretation ensures consistent results among operators Numerical code pad for entering Patient identification Real-time correction for urine color and room temperature for accurate results Analyzer runs alone on 2 AA batteries or from any power outlet via the detachable Printer and AC adapter (included) Memory Storage of the results of the last 100 samples (patients and controls) No calibration required, automatic on every strip Software information requirements Name of software package: N/A Current version # availability: N/A Included download capability:N/A Administration features: N/A QC features External Controls Available through ThermoBioStar for Moderate CAP/JACHO inspected labs. CLIA Waived and Moderate facilities need to follow good laboratory practice with an established routine for running controls. ThermoBioStar offers external controls with 60 day room temperature storage. Reporting features Results are reported on the LCD Display within 17 seconds of analysis. Results can be printed out via the printer and also sent to the LIS via RS232 port. Up to 5 screen captures which show examples of software: see our website for a full animated view of PocketChem www.thermobiostar.com
	Size & Weight	Y2K Compliant	Features	Data transfer capability	Operating System capability	Units test result reported		Instrument Management	LIS Interface capability
	9”x5”x1” 1.5 lbs	Yes Contact ThermoBioStar for information	Reflectance specto- photometer	RS232 Cable Interface and Uni-Directional	Results downloaded via RS232 port	mg/dl, +++, mg/dl, +n, mmol/l,+++, mmol/l,+n		Routine daily cleaning of the Test Strip Holder	In development

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Last updated: 12/08/2008
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