Dimension Vista THC Flex

Reg #: 2517506 · FEI: 2517506 · Expires 2025

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Registration Number: 2517506
FEI Number: 2517506
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: 500 GBC DR, PO Box 6101
City: NEWARK
State: DE
ZIP: 19714
Country: US

Regulatory Submissions

510(k) Number: K062128

Owner / Operator

Firm Name: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Operator Number: 9096044
Address: Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
City: Tarrytown
State: NY
Postal Code: 10591
Country: US
Correspondent: Mary Seeger

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Enzyme Immunoassay, Amphetamine	DKZ	Class 2	Clinical Toxicology	No	2007-11-15
Enzyme Immunoassay, Methadone	DJR	Class 2	Clinical Toxicology	No	2007-11-15
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	Class 2	Clinical Toxicology	No	2007-11-15
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2007-11-15
Enzyme Immunoassay, Benzodiazepine	JXM	Class 2	Clinical Toxicology	No	2007-11-15
Enzyme Immunoassay, Opiates	DJG	Class 2	Clinical Toxicology	No	2007-11-15
Differential Rate Kinetic Method, Cpk Or Isoenzymes	JHS	Class 2	Clinical Chemistry	No	2007-11-15
Assay, Glycosylated Hemoglobin	LCP	Class 2	Hematology	No	2007-11-15
Enzyme Immunoassay, Phencyclidine	LCM	Class U	Unknown	No	2007-11-15
Enzyme Immunoassay, Cannabinoids	LDJ	Class 2	Clinical Toxicology	No	2007-11-15

Proprietary Names

Dimension Vista THC Flex Dimension Vista METH Flex Dimension Vista PCP Flex Dimension Vista BENZ Flex Dimension Vista AMPH Flex Dimension Vista COC Flex Dimension Vista EXTC Flex Dimension Vista OPI Flex Dimension Vista BARB Flex

Establishment Types

Manufacture Medical Device