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510(k) Data Aggregation
K Number
K220016Device Name
Viramed Borrela All-In-One ViraChip Test Kit
Manufacturer
Viramed Biotech AG
Date Cleared
2022-08-19
(226 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
Viramed Biotech AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viramed Biotech AG Borrelia All-In-One ViraChip is an in vitro qualitative microarray assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VIsE and multiple other B. burgdorferi antigens following a modified two-tier test methodology. Positive results from the Viramed Biotech AG Borrelia All-In-One ViraChip are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease.
The Viramed Biotech AG Borrelia All-In-One ViraChip Test must be used with a ViraChip Reader and the ViraChip Software.
Device Description
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K Number
K163695Device Name
Borrelia B31 ViraChip IgM Test Kit
Manufacturer
Viramed Biotech AG
Date Cleared
2017-08-22
(237 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
Viramed Biotech AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viramed Biotech AG Borrelia B31 Viro qualitative protein nicroaray assay for the detection of IgM antibodies to Borreia burgdorfer in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EA or FFA test procedure for B. burgdorferi antibodies. Positive essay are supportive evidence of infection with B. burgdorfer, the causative agent for Lyme disease.
The Viramed Biotech AG Borrelia B31 ViraChip® IgM Test must be used with a ViraChip® Reader and the ViraChip® Software.
Device Description
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K Number
K163504Device Name
Borrelia B31 ViraChip IgG Test Kit
Manufacturer
VIRAMED BIOTECH AG
Date Cleared
2017-07-12
(210 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
VIRAMED BIOTECH AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viramed Biotech AG Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyne disease.
The Borrelia B31 ViraChip® IgG Test Kit must be used with a ViraChip® Reader and the ViraChip® Software.
Device Description
The Viramed Biotech AG Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyne disease.
The Borrelia B31 ViraChip® IgG Test Kit must be used with a ViraChip® Reader and the ViraChip® Software.
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K Number
K092693Device Name
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
Manufacturer
VIRAMED BIOTECH AG
Date Cleared
2009-11-25
(84 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
VIRAMED BIOTECH AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viramed Biotech AG Borrelia B31 IgG ViraStripe® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme discasc. The Viramed Biotech AG Borrelia B31 IgG ViraStripe® can be used anytime after onset of symptoms provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in an line blot assay or Western blot, 2) IgG antibodies were found by line blot or Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested sero-negative individuals are shown to develop antibodies by an EIA or IFA test.
Device Description
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K Number
K082329Device Name
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
Manufacturer
VIRAMED BIOTECH AG
Date Cleared
2009-08-05
(356 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
VIRAMED BIOTECH AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viramed Biotech AG Borrelia B31 IgM ViraStripe® is an in vitro qualitative assay for the detection of IgM antibodies against Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an ElA or IFA test procedure for B. burgdorferi antibodies. Positive results from this line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech AG Borrelia B31 IgM ViraStripe® can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. Patients who are positive by IgM but not IgG should have the test repeated a few weeks later if they remain ill. If they are still positive only by IgM and have been ill longer than one month, this is likely a false positive.
Device Description
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K Number
K051071Device Name
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
Manufacturer
VIRAMED BIOTECH AG
Date Cleared
2005-08-11
(107 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
VIRAMED BIOTECH AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viramed Biotech Borrelia B31 IgG ViraBlot® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.
Device Description
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K Number
K051169Device Name
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
Manufacturer
VIRAMED BIOTECH AG
Date Cleared
2005-08-11
(104 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
VIRAMED BIOTECH AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viramed Biotech Borrelia B31 IgM ViraBlot® is an in vitro qualitative assay for the detection of IgM antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found insitive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease. The Viramed Biotech Borrelia B31 ViraBlot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to be Western blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
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