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510(k) Data Aggregation
K Number
K041748Device Name
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
Manufacturer
Date Cleared
2004-08-09
(41 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
AZOG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AZOG hCG One-Step (Urine) Pregnancy Home Test (DipStick, Cassette and Midstream) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy at home.
AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (DipStick, Cassette and Midstream) are intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in urine. The Test is for the early detection of pregnancy.
Device Description
The AZOG hCG One-Step Urine Pregnancy Home Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine into the sample well of the device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.
Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
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K Number
K022680Device Name
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
Manufacturer
Date Cleared
2002-11-01
(81 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
AZOG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AZOG hCG One-Step (Urine) Pregnancy Test Strip (DipStick) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
AZOG, INC. ACG one-step. Vrine Pregnancy test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human Urine the test is for professional use only.
Device Description
The AZOG hCG One-Step Pregnancy Test Strip (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by immersing the test strip in a urine specimen and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.
Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
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K Number
K022681Device Name
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
Manufacturer
Date Cleared
2002-11-01
(81 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
AZOG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AZOG hCG One-Step (Urine) Pregnancy Test (Device or Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
AZOG, INC. hCG One-Step Urime Pregnancy test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human Urine The test is for professional use only.
Device Description
The AZOG hCG One-Step Pregnancy Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine into the sample well of the device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
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