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Found 8 results
510(k) Data Aggregation
K Number
K051727Device Name
AIMSTICK URINE REAGENT STRIPS
Manufacturer
GERMAINE LABORATORIES, INC.
Date Cleared
2005-10-26
(120 days)
Product Code
CEN, CDM, JIL, JIN, JIO, JIR, JJB, JMT, LJX
Regulation Number
862.1550Why did this record match?
Applicant Name (Manufacturer) :
GERMAINE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AimStick® Urine Reagent Strips are intended for detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes in urine.
The AimStick® Urine Reagent Strips are intended for the qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine for persons to test by visual comparison with a color chart on the bottle label. This product is for professional use. Test results may provide information regarding the status of carbohydrate metabolism, kidney function, liver function, acid-base balance, and bacturia.
Device Description
Plastic strips with reagent pads which provide a color change when exposed to urine.
The AimStick® Urine Reagent Strips are plastic strips to which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged with a drying agent in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The directions must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.
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K Number
K013857Device Name
AIMSTEP PREGNANCY
Manufacturer
GERMAINE LABORATORIES, INC.
Date Cleared
2002-01-22
(62 days)
Product Code
DHA, LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
GERMAINE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
Device Description
The test utilizes a combination of monochonal and polyclonal antibody reagents to selectively devect elevated levels of hCG. The assay is conducted by adding urine to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membranc to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the "Test Region" of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Region will always appear regardless of the presence or absence of hCG.
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K Number
K991369Device Name
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
Manufacturer
GERMAINE LABORATORIES, INC.
Date Cleared
1999-05-10
(20 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
GERMAINE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy is intended for non-professional over-the-counter use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
Device Description
The test utilizes a combination of monoclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored liness. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specific antibody-hCG-colored conjugate and form a colored line on the Specimen portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Zone will always appear regardless of the presence or absence of hCG.
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K Number
K981165Device Name
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
Manufacturer
GERMAINE LABORATORIES, INC.
Date Cleared
1998-04-16
(16 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
GERMAINE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AimStep™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.
Device Description
The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored coningate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.
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K Number
K980531Device Name
AIMSTEP PREGNANCY
Manufacturer
GERMAINE LABORATORIES, INC.
Date Cleared
1998-03-06
(23 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
GERMAINE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AimStep™ Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the early determination of pregnancy. This test is for professional use.
Device Description
The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. 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 and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
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K Number
K974368Device Name
AIMSTICK PBD PREGNANCY
Manufacturer
GERMAINE LABORATORIES, INC.
Date Cleared
1998-01-02
(43 days)
Product Code
DHA
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
GERMAINE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.
Device Description
The test utilizes a combination of momelonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. 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 and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence of hCG.
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K Number
K974512Device Name
AIMSTICK PBD COMBO PREGNANCY
Manufacturer
GERMAINE LABORATORIES, INC.
Date Cleared
1998-01-02
(32 days)
Product Code
DHA
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
GERMAINE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AimStick™ PBD Combo Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine or serum to aid in the determination of pregnancy. This test is for professional use.
Device Description
The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of hCG. The test strip is inserted into the specimen and the formation of colored bands is observed. 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 and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
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K Number
K973825Device Name
MIDSTREAM HOME REGNANCY TEST
Manufacturer
GERMAINE LABORATORIES, INC.
Date Cleared
1997-12-19
(73 days)
Product Code
DHA, LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
GERMAINE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MidStream™ Home Pregnancy Test is intended for nonprofessional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
Device Description
The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by urinating on the absorbent wick and observing for the formation of colored bands. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
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