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510(k) Data Aggregation
K Number
K000979Device Name
REDI-SCREEN
Manufacturer
Date Cleared
2000-04-10
(14 days)
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
REDWOOD BIOTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Redi-Screen is a qualitative, one step, immunochromatographic competitive assay for the qualitative determination of the presence of THC, Phencyclidine, Opiates, Cocaine and Methamphetamine at the following cut off concentrations;
| THC | 50ng/mL |
|-----------------|------------|
| PCP | 25ng/mL |
| Opiates | 300ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1,000ng/mL |
The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
This test is for use in clinical laboratories by health care and forensic professionals only.
Device Description
The Redi-Screen is an immunochromatographic based one step in vitro test.
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K Number
K993100Device Name
REDI-SCREEN
Manufacturer
Date Cleared
1999-10-06
(20 days)
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
REDWOOD BIOTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Redi-Screen is designed for the qualitative determination of five (5) DOA and their metabolites in human urine specimens. The five DOA include THC, PCP, Opiates, Cocaine and Methamphetamine. The presence of these drugs and their cross-reacting metabolites in human urine can be detected above the following cut off levels:
THC 50ng/mL
PCP 25ng/mL
Opiates 300ng/mL
Cocaine 300ng/mL
Methamphetamine 1,000ng/mL
The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS,
This test is for use in clinical laboratories by health care and forensic professionals only.
Device Description
The Redi-Screen is an immunochromatographic based one step in vitro test.
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K Number
K991698Device Name
REDI-TEST PCP
Manufacturer
Date Cleared
1999-08-25
(99 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
REDWOOD BIOTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Redi-Test PCP is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of phencyclidine at a cut off concentration of 25ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
Device Description
The Redi-Test PCP is an immunochromatograpic based one step in vitro test.
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K Number
K991110Device Name
REDI-TEST COCAINE
Manufacturer
Date Cleared
1999-07-26
(116 days)
Product Code
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
REDWOOD BIOTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Redi-Test Cocaine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the cocaine metabolite, benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
Device Description
The Redi-Test Cocaine is an immunochromatograpic based one step in vitro test.
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K Number
K991504Device Name
REDI-TEST METHAMPHETAMINE
Manufacturer
Date Cleared
1999-07-22
(84 days)
Product Code
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
REDWOOD BIOTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Redi-Test Methamphetamine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of d, methamphetamine at a cutoff concentration of 1000ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
Device Description
The Redi-Test Methamphelamine is an immunochromatographic based one step in vitro lest.
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K Number
K990870Device Name
REDI-TEST THC
Manufacturer
Date Cleared
1999-04-27
(42 days)
Product Code
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
REDWOOD BIOTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Redi-Test THC is designed for the qualitative determination of cannabinoids (THC) and its metabolites in human urine specimens. The presence of 11nor-Δ°-ΤΗC-9-COOH in human urine as low as 50 ng/ml can be detected. This test is for use in clinical laboratories by health care professionals and forensic professionals only.
The Redi-Test THC is a rapid immunochromatographic competitive assay used to screen human urine for the presence of cannabinoids at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed by an alternate methodology preferably GC/MS.
Device Description
The Redi-Test THC is an immunochromatograpic based one step in vitro test.
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