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Found 36 results
510(k) Data Aggregation
K Number
K070262Device Name
ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Manufacturer
OXOID, LTD.
Date Cleared
2007-03-14
(47 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Ertapenem these include: Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pneumoniae (penicillin susceptible isolates only), Streptococcus pyogenes, Escherichia coli, Haemophilus influenzae (Beta-lactamase negative isolates only), Klebsiella pneumoniae, Moraxella catarrhalis, and Proteus mirabilis.
Device Description
Not Found
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K Number
K060286Device Name
TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Manufacturer
OXOID, LTD.
Date Cleared
2006-03-17
(42 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tigecycline is indicated for Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and by modified procedures Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pnemoniae.
Device Description
Not Found
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K Number
K042157Device Name
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Manufacturer
OXOID, LTD.
Date Cleared
2004-09-14
(35 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Daptomycin these include Staphylococcus aureus (including MRSA), Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, Streptococcus pneumoniae, and Enterococcus faecalis (vancomycin-susceptible strains only).
Device Description
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K Number
K011710Device Name
OXOID PBP2 1 LATEX AGGLUTINATION TEST
Manufacturer
OXOID, LTD.
Date Cleared
2002-04-02
(302 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.
Device Description
PBP21 Latex Agglutination Test
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K Number
K012588Device Name
OXOID PYLORI TEST KIT, MODEL DR0130M
Manufacturer
OXOID, LTD.
Date Cleared
2001-12-10
(122 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oxoid Pylori Test Kit is a rapid latex agglutination test for the qualitative detection of Helicobacter onlori total antibodies in serum as an aid in the diagnosis of infections by H. pylori. The product is intended for use to test patients 18 years and older, with symptoms of gastro-intestinal disorders.
Device Description
rapid latex agglutination test
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K Number
K010536Device Name
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Manufacturer
OXOID, LTD.
Date Cleared
2001-04-24
(60 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010537Device Name
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Manufacturer
OXOID, LTD.
Date Cleared
2001-04-24
(60 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000930Device Name
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Manufacturer
OXOID, LTD.
Date Cleared
2000-05-22
(61 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000928Device Name
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Manufacturer
OXOID, LTD.
Date Cleared
2000-05-15
(54 days)
Product Code
JTN
Regulation Number
866.1620Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993401Device Name
DRYSPOT E.COLI 0157 KIT
Manufacturer
OXOID, LTD.
Date Cleared
2000-02-28
(143 days)
Product Code
GNA
Regulation Number
866.3255Why did this record match?
Applicant Name (Manufacturer) :
OXOID, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oxoid Dryspot E.coli 0157 test is a latex agglutination test for the identification of E.coli serogroup 0157 in colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement. The test is not indicated for direct testing of faccal specimens.
Device Description
latex agglutination test
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