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Found 11 results
510(k) Data Aggregation
K Number
DEN140001Device Name
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2014-08-20
(65 days)
Product Code
PHF
Regulation Number
866.5670Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
Device Description
The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay contains the following: strip wells coated with ZnT8 (96 wells in total) and supplied as 12 strips of 8 wells in a frame and sealed in a foil bag with desiccant; ready-to-use 4 levels of calibrators (10, 20, 75, and 500 U/mL, 5x0.7 mL each); one each ready-to-use positive I, positive II and negative control serum (1x0.7 mL); Zinc T8 Biotin (lyophilized) 3x5.5 mL (reconstituted); ready-to-use reconstitution buffer for Zinc T8 Biotin 2x15 mL (colored red); Streptavidin Peroxidase (SA-POD dilute before use) 1x0.7 mL; ready-to-use diluent for SA-POD 1x15 mL; ready-to-use peroxidase substrate (TMB) 1x15 mL; concentrated wash solution (dilute with deionized water before use) 1x125 mL and ready-to-use stop solution 1x12 mL.
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K Number
K121046Device Name
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2012-12-20
(258 days)
Product Code
PCG
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit is for the semiquantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The KRONUS Steroid 21-OHAb RIA Assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
Device Description
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K Number
K111956Device Name
KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2012-05-30
(324 days)
Product Code
PAF
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit is for the semiquantitative determination of antibodies to voltage gated calcium channels in human serum. The VGCC antibody may be present in patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS). The assay result is not to be used alone and is to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.
Device Description
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K Number
K080523Device Name
KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2008-06-17
(112 days)
Product Code
NST
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS Blocking AChRAb RIA Assay Kit is for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor in human serum. The KRONUS Blocking AChRAb Assay is useful as an aid in the diagnosis of myasthenia gravis (MG).
Device Description
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K Number
K080159Device Name
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2008-05-22
(120 days)
Product Code
JZO
Regulation Number
866.5870Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS TRAb ELISA Assay Kit is for the semi-quantitative determination of antibodies to the thyroid stimulating hormone receptor in human serum. The KRONUS TRAb ELISA Assay is useful as an aid in the diagnosis of Graves' Disease in conjunction with other clinical and laboratory findings.
Device Description
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K Number
K073590Device Name
KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2008-04-10
(112 days)
Product Code
OIF
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
Device Description
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K Number
K072135Device Name
KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2007-11-07
(97 days)
Product Code
NWG
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K070183Device Name
KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2007-07-13
(175 days)
Product Code
OCN
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
Device Description
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K Number
K051061Device Name
KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2005-11-04
(192 days)
Product Code
NWG
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
Device Description
KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit
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K Number
K042248Device Name
KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2004-12-17
(120 days)
Product Code
NST
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KRONUS Acetylcholine Receptor Antibody (AChRAb) Assay Kit is for the quantitative or qualitative determination of acetylcholine receptor antibody in human serum. The KRONUS Acetylcholine Receptor Antibody(AChRAb) kit is useful as an aid in the differential diagnosis of Myasthenia Gravis.
Device Description
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