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Found 7 results
510(k) Data Aggregation
K Number
K100031Device Name
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
Manufacturer
IND DIAGNOSTIC INC.
Date Cleared
2010-07-19
(194 days)
Product Code
KHE
Regulation Number
864.6550Why did this record match?
Applicant Name (Manufacturer) :
IND DIAGNOSTIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.
Device Description
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K Number
K063390Device Name
URINE CHEMISTRY ANALYZER UR-50
Manufacturer
IND DIAGNOSTIC INC.
Date Cleared
2007-03-01
(112 days)
Product Code
JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, KQO, LJX
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
IND DIAGNOSTIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Urine Chemistry Analyzer UR-50 is for use with the IND Urinalysis Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity in urine. It can be used for testing in the clinical laboratory setting. For professional use only. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
Device Description
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K Number
K060810Device Name
ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
Manufacturer
IND DIAGNOSTIC INC.
Date Cleared
2006-08-07
(136 days)
Product Code
DKZ, DIO, DJG, LAF, LDJ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
IND DIAGNOSTIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mL Marijuana, 300 ng/mL Morphine, 1000 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetamine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person.
For in vitro diagnostic use only.
As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method
Device Description
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K Number
K052694Device Name
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
Manufacturer
IND DIAGNOSTIC INC.
Date Cleared
2005-12-16
(79 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
IND DIAGNOSTIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
One Step HCG Pregnancy Test 2000 mIU / mL is a qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL designed to aid in the detection of pregnancy. This test device is intended for professional central laboratory use only.
Device Description
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K Number
K052662Device Name
ONE STEP FSH MENOPAUSAL TEST
Manufacturer
IND DIAGNOSTIC INC.
Date Cleared
2005-11-30
(64 days)
Product Code
CGJ
Regulation Number
862.1300Why did this record match?
Applicant Name (Manufacturer) :
IND DIAGNOSTIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FSH Menopausal Test is a rapid Step The One chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of the onset of menopause. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH. This device is intended for both professional and lay person use.
Device Description
One Step FSH Menopausal Test is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH.
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K Number
K050741Device Name
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
Manufacturer
IND DIAGNOSTIC INC.
Date Cleared
2005-05-16
(56 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
IND DIAGNOSTIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are intended for professional use.
Device Description
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K Number
K023638Device Name
CASSETTE/URINE HCG
Manufacturer
IND DIAGNOSTIC INC.
Date Cleared
2003-01-03
(65 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
IND DIAGNOSTIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy. This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.
Device Description
Urine RCG (Cassette Format) One Step Test Kit
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