DEVICE: VIDAS® B·R·A·H·M·S PCT ™ (03573026223601)

Device Identifier (DI) Information

VIDAS® B·R·A·H·M·S PCT ™
30450-01
In Commercial Distribution

BIOMERIEUX SA
03573026223601
GS1

1
276816717 *Terms of Use
VIDAS ® B·R·A·H·M·S PCT™ (PCT) is an automated test for use on the VIDAS ® instruments for the determination of procalcitonin in human serum or plasma.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
61534 Procalcitonin (PCT) IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of procalcitonin (PCT) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as a marker of bacterial sepsis or severe bacterial infection.
Active false
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FDA Product Code

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Product Code Product Code Name
NTM Antigen, Inflammatory Response Marker, Sepsis
PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
PRI Procalcitonin Assay
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K071146 000
K160911 000
K162827 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 2 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

eae7fa54-29ea-4d48-96b0-146e0a7c8b4d
February 06, 2025
4
September 23, 2016
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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No Customer Contact currently defined
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