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Found 3 results
510(k) Data Aggregation
K Number
K092450Device Name
HUMAN IGD KIT FOR USE ON SPAPLUS
Manufacturer
THE BINDING SITE
Date Cleared
2009-12-28
(140 days)
Product Code
CZJ
Regulation Number
866.5510Why did this record match?
Product Code :
CZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for measuring human immunoglobulin D (IgD) in serum as an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings.
Device Description
Not Found
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K Number
K051299Device Name
IGD DIAGNOSTIC TEST KITS
Manufacturer
THE BINDING SITE LTD.
Date Cleared
2005-11-23
(189 days)
Product Code
CZJ
Regulation Number
866.5510Why did this record match?
Product Code :
CZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for measuring human Immunoglobulin D (IgD) in serum as an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Device Description
Not Found
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K Number
K002561Device Name
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2000-10-26
(70 days)
Product Code
CZJ
Regulation Number
866.5510Why did this record match?
Product Code :
CZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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