DEVICE: Alethia™ (00840733101663)

Device Identifier (DI) Information

Alethia™
610189
In Commercial Distribution
610189
MERIDIAN BIOSCIENCE, INC.
00840733101663
GS1

1
092815364 *Terms of Use
Alethia™ is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc.’s Alethia Loop-Mediated Amplification assays.
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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?
48030 Isothermal nucleic acid amplification analyser IVD, laboratory
An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen at a constant (isothermal) temperature, using a series of transcription and reverse transcription reactions, and to detect and/or identify the amplified product using oligonucleotide markers as it is produced (e.g., in real-time).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OOI Real Time Nucleic Acid Amplification System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K100818 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e1c3e2cb-340d-4a97-bce8-ce3e2edcb1ab
September 28, 2023
3
January 08, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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
Yes
No
No
No CLOSE

Customer Contact

[?]
800-343-3858
MBI-TechService@meridianbioscience.com
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