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Found 34 results
510(k) Data Aggregation
K Number
K061769Device Name
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2006-07-03
(10 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
e.p.t Certainty® 1-Step Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.
Device Description
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K Number
K060128Device Name
CLEARBLUE EASY DIGITAL PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2006-05-25
(127 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clearblue Easy Digital Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.
Device Description
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K Number
K051638Device Name
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
Manufacturer
UNIPATH LTD.
Date Cleared
2005-12-06
(169 days)
Product Code
GTY
Regulation Number
866.3740Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inverness Medical TestPack + Plus Strep A with OBC Test is intended for the qualitative detection of Group A Streptococcal (Group A Strep) antigen in throat swab specimens from patients with suspected Group A Strep associated pharyngitis and for confirmation of presumptive Group A Strep colonies isolated on culture plates. The test is intended for Professional and Laboratory Use only.
Device Description
Inverness Medical TestPack + Plus Strep A with OBC Strep A is an immunoassay employing sheep and rabbit polyclonal antibodies and gold colloid particles. The test device uses lateral flow technology; following antigen extraction, the test time is approximately 5 minutes. The Streptococcal Group A specific antigen is extracted from the throat swab using Reagent 1 (2.0 M Sodium Nitrite (& Xylenol Orange) and Reagent 2 (1.0 M Acetic Acid). Following this, Reagent 3 (1.0 M Tris Buffer) is added to neutralise the acid formed by Reagents 1 and 2. The mixture is then dropped into the sample well of the reaction disc from which it migrates through the membrane until it reaches the End of Assay (EOA) Window. As the specimen extract migrates through the membrane, it mobilises the antibody-coated colloid (colloid coated with Rabbit Anti-Strep A antibody). If Group A Streptococcal antigen is present in the specimen it will form a complex with the antibody-colloid. The antibody colloid complex migrates through the membrane and is then captured by the Group A Strep antibody (Sheep polyclonal antibody) in the result window, providing a visual indication of the presence of antigen. The test can be read when the 'End of Assay' (EOA) window has turned pink / red. A pink / red Plus Sign (+) appearing in the result window indicates the presence of the Group A Strep antigen. A Minus Sign (-) indicates no antigen was detected. The device also includes integral Control features.
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K Number
K050930Device Name
E.P.T. CERTAINTY PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2005-05-12
(28 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
e.p.t CertaintyTM Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from the first day of the expected period and thereafter, but can also be used from three days before the expected period.
Device Description
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K Number
K042280Device Name
FACT PLUS ONE-STEP PREGNANCY TEST KIT
Manufacturer
UNIPATH LTD.
Date Cleared
2004-09-10
(18 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fact plus® One-Step Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.
Device Description
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K Number
K041404Device Name
CLEARBLUE EASY EASY READ PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2004-06-08
(13 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine. The test is indicated for use from three days before the expected period.
Device Description
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K Number
K040329Device Name
MODIFICATION TO E.P.T. PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2004-03-08
(26 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and onwards.
Device Description
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K Number
K040341Device Name
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2004-03-08
(25 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clearblue Easy Earliest Results Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.
Device Description
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K Number
K033658Device Name
E.P.T. PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2004-01-16
(56 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and may be used before the expected period.
Device Description
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K Number
K032939Device Name
EPT CERTAINTY PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2003-10-20
(28 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
UNIPATH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EPT Certainty™ Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.
Device Description
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