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510(k) Data Aggregation
K Number
K121122Device Name
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
Manufacturer
BIOCHEMICAL DIAGNOSTIC, INC.
Date Cleared
2012-07-03
(81 days)
Product Code
DIF
Regulation Number
862.3280Why did this record match?
Applicant Name (Manufacturer) :
BIOCHEMICAL DIAGNOSTIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
Device Description
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K Number
K050328Device Name
PREGNANCY-SKREEN
Manufacturer
BIOCHEMICAL DIAGNOSTIC, INC.
Date Cleared
2005-03-29
(48 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
BIOCHEMICAL DIAGNOSTIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pregnancy-Skreen™ controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
The Biochemical Diagnostics, Inc., Pregnancy-Skreen™ urine controls are intended to validate the performance of qualitative hCG methods. They should be used as an external quality control to monitor the performance of the "specimen while following the specific protocol of the assay being used. This product is intended to be used by health care professionals as an integral part of good laboratory practices.
Device Description
These products are manufactured in a liquid matrix solution prepared with negative human urine, chemicals, and preservatives. The matrix is not known to interfere with any immunoassay procedures including those used in handheld devices. The positive control is spiked in a target range of 200-400 mIU of Human Chorionic Gonadotropin per mL of urine.
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