DEVICE: PREMIER Adenoclone Type 40/41 (00840733101748)

Device Identifier (DI) Information

PREMIER Adenoclone Type 40/41
696006
In Commercial Distribution
696006
MERIDIAN BIOSCIENCE, INC.
00840733101748
GS1

1
092815364 *Terms of Use
Premier Adenoclone-Type 40/41 is an enzyme immunoassay (EIA) for the qualitative detection of enteric adenovirus serotypes 40 and 41 in human fecal specimens.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
49853 Adenovirus antigen 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 antigens from Adenovirus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K881894 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 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

324d3ee9-4f36-4dbb-828e-af70b29b64da
September 29, 2020
1
September 21, 2020
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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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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
5132713700
info@meridianbioscience.com
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