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510(k) Data Aggregation
K Number
K990842Device Name
SAS ROTA TEST
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
1999-08-09
(147 days)
Product Code
LIQ
Regulation Number
866.3405Why did this record match?
Product Code :
LIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SASTM Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by rotavirus infection. This test is for professional use only.
Device Description
rapid, membrane-based immunogold assay
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K Number
K972895Device Name
VIDAS ROTAVIRUS (RTV) ASSAY
Manufacturer
BIOMERIEUX VITEK, INC.
Date Cleared
1997-10-03
(59 days)
Product Code
LIQ
Regulation Number
866.3405Why did this record match?
Product Code :
LIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIDAS Rotavirus (RTV) Assay is for the qualitative detection of rotavirus antigen in stool specimens. It is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis.
Device Description
The VIDAS Rotavirus (RTV) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS (Vitek ImmunoDiagnositic Assay System) instrument. All assay steps and the assay temperature are controlled by the instrument.
The VIDAS Rotavirus Assay contains a pipette tip-like disposable device, the Solid Phase Receptacle (SPR), a Reagent Strip, 1 Bottle of Standard, 1 Bottle of Positive Control, and 1 Bottle of Negative Control. The Kit contains a sufficient number of SPR's and Strips to perform 60 Tests.
The SPR serves as the solid phase, as well as, the pipettor for the assay. The SPR is coated with rabbit anti-rotavirus antibodies. The Strip contains the reagents necessary to perform the assay, as well as, a sample well for placement of the specimen. Each RTV Assay requires one RTV Reagent Strip and one RTV SPR.
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K Number
K971585Device Name
IMMUNOCARD STAT! ROTAVIRUS
Manufacturer
MERIDIAN DIAGNOSTICS, INC.
Date Cleared
1997-08-20
(111 days)
Product Code
LIQ
Regulation Number
866.3405Why did this record match?
Product Code :
LIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.
Device Description
The ImmunoCard STAT! Rotavirus assay system is a membrane based immunogold assay for rotavirus. Each kit contains the following components: ImmunoCard STAT! Rotavirus devices(30), Positive Control (1.8ml), Sample Diluent (10.5ml), Transfer Pipets (30). In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip.
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K Number
K964424Device Name
ROTAVIRUS EIA
Manufacturer
TRINITY BIOTECH, INC.
Date Cleared
1997-08-08
(276 days)
Product Code
LIQ
Regulation Number
866.3405Why did this record match?
Product Code :
LIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinity Biotech Rotavirus EIA kit is intended for the detection of rotavirus antigen in human fecal specimens and is used as an aid in the diagnosis of acute gastroenteritis caused by rotavirus in children and infants. The performance characteristic was not determined in the elderly population.
Device Description
Not Found
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K Number
K965092Device Name
VIDAS ROTAVIRUS ASSAY
Manufacturer
BIOMERIEUX VITEK, INC.
Date Cleared
1997-05-05
(137 days)
Product Code
LIQ
Regulation Number
866.3405Why did this record match?
Product Code :
LIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens.
Device Description
The VIDAS RTV Assay detects the presence of rotavirus antigen in stool specimens. Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.
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K Number
K951208Device Name
ROTA-DAN RAPID ROTAVIRUS EIA KIT
Manufacturer
ELDAN TECHNOLOGIES, LTD.
Date Cleared
1996-02-14
(334 days)
Product Code
LIQ
Regulation Number
866.3405Why did this record match?
Product Code :
LIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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