Search Results
Found 26 results
510(k) Data Aggregation
K Number
K003104Device Name
BACT/ALERT CSR
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
2000-10-20
(52 days)
Product Code
LJF
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K000492Device Name
MDA D-DIMER
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
2000-06-07
(113 days)
Product Code
DAP
Regulation Number
864.7320Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K000378Device Name
BACT/ALERT MB CULTURE BOTTLE
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
2000-03-02
(24 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K994343Device Name
BACT/ALERT SV
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
2000-02-10
(49 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BacT/ALERT SV Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Device Description
The BacT/ALERT SV Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SV Bottle.
Ask a Question
K Number
K993423Device Name
BACT/ALERT SA
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
1999-12-15
(64 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Device Description
The BacT/ALERT SA Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SA Bottle.
Ask a Question
K Number
K993421Device Name
BACT/ALERT SN
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
1999-12-14
(63 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms (bacteria) from blood and other normally sterile body fluids.
Device Description
The BacT/ALERT SN Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SN Bottle.
Ask a Question
K Number
K993576Device Name
BACT/ALERT MP PROCESS BOTTLE
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
1999-12-14
(54 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the The DacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.
Device Description
The BacT/ALERT MP Process Bottle was developed for the same intended use as the current MB/BacT Process Bottle, provide suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids. An inoculated bottle is placed into the MB/ BacT Detection Instrument or the BacT/ALERT 3D Instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP Process Bottle.
Ask a Question
K Number
K992432Device Name
BACT/ALERT FN
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
1999-09-24
(65 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids.
Device Description
The BacT/ALERT FN Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instrument where it is incubated and continously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Culture Bottle.
Ask a Question
K Number
K983762Device Name
NUCLISENS CMV PP67
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
1999-09-15
(324 days)
Product Code
LIN
Regulation Number
866.3175Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the NucliSens® Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors.
Device Description
The NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the NucliSens®™ Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors.
The NucliSens® CMV pp67 assay is comprised of four separate stages:
- Nucleic acid release
- Nucleic acid isolation
- Nucleic acid amplification
- Nucleic acid detection
Ask a Question
K Number
K992400Device Name
BACTALERT FA
Manufacturer
ORGANON TEKNIKA CORP.
Date Cleared
1999-09-03
(46 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
ORGANON TEKNIKA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids.
Device Description
The BacT/ALERT FA Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA Bottle.
Ask a Question
Page 1 of 3