Search Results
Found 3 results
510(k) Data Aggregation
K Number
K031607Device Name
ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
Manufacturer
ORION DIAGNOSTICA, DIV. ORION CORP.
Date Cleared
2003-10-10
(141 days)
Product Code
DCK
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
ORION DIAGNOSTICA, DIV. ORION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orion Diagnostica QuikRead CRP is a quantitative assay of CRP (C-reactive protein) in whole blood or plasma, using the QuikRead® 101 Instrument. Measurement of CRP helps to evaluate the acute inflammatory processes induced by infectious microbial agents or non-infectious inflammatory stimuli. QuikRead CRP Control is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument. For in vitro diagnostic use.
Device Description
Orion Diagnostica QuikRead® CRP Kit and QuikRead CRP Control
Ask a Question
K Number
K022176Device Name
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
Manufacturer
ORION DIAGNOSTICA, DIV. ORION CORP.
Date Cleared
2002-12-03
(153 days)
Product Code
DCK
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
ORION DIAGNOSTICA, DIV. ORION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orion Diagnostica High Sensitivity CRP (HS-CRP) is an in vitro diagnostic assay intended for the quantification of low concentrations (ca. 0.25 - 10.0 mg/l) of C-reactive protein (CRP) in human serum or plasma (EDTA or heparin) by means of particle enhanced immunoturbidimetry using a Hitachi 911 or 917 analyzer. The measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Device Description
Not Found
Ask a Question
K Number
K971537Device Name
PYLORISET EIA-G (68926)
Manufacturer
ORION DIAGNOSTICA, DIV. ORION CORP.
Date Cleared
1997-06-27
(60 days)
Product Code
LYR, CLA
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
ORION DIAGNOSTICA, DIV. ORION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pyloriset EIA-G is a qualitative enzyme immunoassay for the detection of Helicobacter pylori specific IgG antibodies in human serum as an aid in diagnosing infection by H. pylori. The product is intended for use to test patients with symptoms of gastrointestinal disorders.
Device Description
Pyloriset EIA-G is a qualitative enzyme immunoassay.
Ask a Question
Page 1 of 1