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Found 2 results

510(k) Data Aggregation

K Number

Device Name

TREP-SURE TREPONEMAL ANTIBODY EIA

Manufacturer

PHOENIX BIOTECH CORP.

Date Cleared

2006-08-07

(228 days)

Product Code

LIP

Regulation Number

866.3830

Why did this record match?

Applicant Name (Manufacturer) :

PHOENIX BIOTECH CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

TREP-SURE EIA is a qualitative enzyme immunoassay for the in vitro diagnostic detection of Treponema pallidum (syphilis) antibodies in human serum or plasma. This product can be used as an initial screening test or as a confirmatory diagnostic test, but is not cleared (approved) by the U.S. Food and Drug Administration (FDA) for use in screening blood or plasma donors.

Device Description

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K Number

Device Name

TREPCHEK TREPONEMAL ANTIBODY EIA

Manufacturer

PHOENIX BIOTECH CORP.

Date Cleared

2000-10-19

(154 days)

Product Code

LIP

Regulation Number

866.3830

Why did this record match?

Applicant Name (Manufacturer) :

PHOENIX BIOTECH CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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