DEVICE: COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets) (B379RCFPCK201)

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Device Identifier (DI) Information
COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets)
RCFP-CK20
In Commercial Distribution

INBIOS INTERNATIONAL, INC
B379RCFPCK201
HIBCC

1
004006628 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
Yes
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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?
48247 Multiple-genus respiratory virus antigen IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
Active false
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization
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No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
6be0133e-da45-42bb-ad98-81c62460a786
October 14, 2025
1
October 06, 2025
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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
No
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No
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Customer Contact

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No Customer Contact currently defined
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