DEVICE: ImmunoDOT Borrelia Test (00613745050256)
Device Identifier (DI) Information
ImmunoDOT Borrelia Test
800-5025
In Commercial Distribution
5025
Genbio
800-5025
In Commercial Distribution
5025
Genbio
The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test for the qualitative detection of Borrelia antibodies. Both species specific (anti-P39) and related Borrelia burgdorferi antibodies (IgG, IgM, and IgA) are detected in serum as an aid in the diagnosis of Lyme disease.
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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50555 | Borrelia burgdorferi total antibody IVD, kit, immunoblot |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.
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FDA Product Code
[?]Product Code | Product Code Name |
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LSR | Reagent, Borrelia Serological Reagent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K911627 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 25 tests |
Device Record Status
c1fa7f40-d80b-40a7-816e-cd63fd7183d9
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
858-592-9300
support@genbio.com
support@genbio.com