DEVICE: Liofilchem MTS (MIC Test Strip) (08055182872893)
Device Identifier (DI) Information
Liofilchem MTS (MIC Test Strip)
Eravacycline ERV 0.002-32 µg/mL 1 STRIP
In Commercial Distribution
92104-1
LIOFILCHEM SRL
Eravacycline ERV 0.002-32 µg/mL 1 STRIP
In Commercial Distribution
92104-1
LIOFILCHEM SRL
The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of
bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to
determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight
incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of
incubation.
MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria.
Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label:
Gram-positive bacteria
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Gram-negative bacteria
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label:
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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63218 | Eravacycline minimum inhibitory concentration (MIC) IVD |
A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial eravacycline, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JWY | Manual Antimicrobial Susceptibility Test Systems |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K182557 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9147a066-4d07-4dd5-8dad-3683d8524ce3
December 10, 2018
1
November 09, 2018
December 10, 2018
1
November 09, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
28055182872897 | 30 | 08055182872893 | In Commercial Distribution | Box | |
18055182872890 | 10 | 08055182872893 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined