DEVICE: Remel (00848838027031)

Device Identifier (DI) Information

Remel
R24600
In Commercial Distribution

REMEL, INC.
00848838027031
GS1

20
065769564 *Terms of Use
Xpect Flu A&B KT/20TST
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
49119 Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PSZ Devices Detecting Influenza A, B, And C Virus Antigens
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092423 000
No 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

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

b9612d5f-1cd6-474a-98e0-7266120ddf84
June 10, 2022
3
November 12, 2021
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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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 30848838027032 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8002556730
csemail@thermofisher.com
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