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Found 9 results
510(k) Data Aggregation
K Number
K160070Device Name
Rheumatoid Factor (RF) Kit for use on SPAPLUS
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2016-12-07
(329 days)
Product Code
DHR
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rheumatoid Factor (RF) Kit for use on SPAPLUS is intended for the quantitative in vitro measurement of rheumatoid factors in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K140396Device Name
FREELITE HUMAN LAMBDA FREE KIT
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2014-04-16
(57 days)
Product Code
DEH
Regulation Number
866.5550Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The kit is intended for the quantitation of lambda free light chains in serum and urine on Binding Site SPAPLUS. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition dissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis and light chain deposition with other laboratory and clinical findings.
Device Description
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K Number
K140664Device Name
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2014-04-16
(29 days)
Product Code
DEB
Regulation Number
866.5620Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is designed for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K123256Device Name
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2013-07-03
(258 days)
Product Code
DEM
Regulation Number
866.5130Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K121045Device Name
HUMAN ALBUMIN CSF KIT
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2013-06-19
(439 days)
Product Code
DCF
Regulation Number
866.5040Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K122965Device Name
HUMAN CAERULOPLASMIN KIT
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2013-06-03
(252 days)
Product Code
DDB
Regulation Number
866.5210Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Human Ceruloplasmin Kit for use on SPAPlus is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPAPLUS turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K120901Device Name
HUMAN IGA CSF KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2013-05-30
(430 days)
Product Code
CFN
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Human IgA CSF Kit for use on SPAPLUS is intended for the quantitative measurement of human IgA in cerebrospinal fluid (CSF) samples using the SPAPLUS analyser. Measurement of this immunoglobulin aids in the assessment of the body's lack of ability to resist infectious disease in conjunction with other clinical and laboratory findings.
Device Description
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K Number
K122304Device Name
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2013-04-15
(257 days)
Product Code
DBA
Regulation Number
866.5250Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K100179Device Name
SPAPLUS
Manufacturer
THE BINDING SITE GROUP, LTD.
Date Cleared
2010-08-13
(204 days)
Product Code
CZW
Regulation Number
866.5240Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.
Device Description
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