DEVICE: Liofilchem MTS (MIC Test Strip) (18055182870001)
Device Identifier (DI) Information
Liofilchem MTS (MIC Test Strip)
Dalbavancin DAL 0.002-32 100 Strip Canister
In Commercial Distribution
921370
LIOFILCHEM SRL
Dalbavancin DAL 0.002-32 100 Strip Canister
In Commercial Distribution
921370
LIOFILCHEM SRL
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
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? |
---|---|---|---|---|
37300 | Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit |
A collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterials against a specific bacterial microorganism, isolated from a clinical specimen by culture.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JWY | Manual Antimicrobial Susceptibility Test Systems |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K153569 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
43167b6a-c0e3-4a00-aabe-6208ac2c0935
February 04, 2022
1
January 27, 2022
February 04, 2022
1
January 27, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
08055182870004
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined