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
08055182872893
GS1

1
435342134 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
Yes
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GMDN

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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?
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.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
JWY Manual Antimicrobial Susceptibility Test Systems
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K182557 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -20 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9147a066-4d07-4dd5-8dad-3683d8524ce3
December 10, 2018
1
November 09, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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