DEVICE: APIWEB™ (03573026133542)

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Device Record History
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Device Identifier (DI) Information
APIWEB™
1.4
In Commercial Distribution

BIOMERIEUX SA
03573026133542
GS1

1
276816717 *Terms of Use
APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
61487 Human infectome analysis interpretive software IVD
An in vitro diagnostic interpretive software program intended to be used to aid the identification of infectious microbial species [bacterial, fungal, viral] in a clinical specimen using images from microbial cultures and laboratory biochemical tests (e.g., digital profiles), or by genetic profiling via nucleic acid analysis. Results from in vitro diagnostic tests are input and the presumptive name(s), probability of possible microbial species, and/or information on genetic variants (e.g., subtype, genotype, strain) are returned.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OUG Medical device data system
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
2a41adc5-92c1-48d8-ab07-18108d8517fd
April 11, 2022
1
April 01, 2022
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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
No Package DIs found
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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