DEVICE: COVID-19 Coronavirus Real Time PCR Kit (06973342000530)
Device Identifier (DI) Information
COVID-19 Coronavirus Real Time PCR Kit
25 Tests
In Commercial Distribution
Jiangsu Bioperfectus Technologies Co., Ltd.
25 Tests
In Commercial Distribution
Jiangsu Bioperfectus Technologies Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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64747 | SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
07753f87-f786-4f63-9601-875f437c763e
February 10, 2023
1
February 02, 2023
February 10, 2023
1
February 02, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined