DEVICE: QUANTA Lite® H.pylori IgA ELISA (08426950593805)
Device Identifier (DI) Information
QUANTA Lite® H.pylori IgA ELISA
708720
In Commercial Distribution
INOVA DIAGNOSTICS, INC.
708720
In Commercial Distribution
INOVA DIAGNOSTICS, INC.
1. 1x H. pylori IgA ELISA microwell plate, (12-1 x 8 wells), with holder
2. 1x 1.2mL prediluted ELISA Negative Control
3. 1x 1.2mL prediluted H. pylori IgA ELISA Low Positive
4. 1x 1.2mL prediluted H. pylori IgA ELISA High Positive
5. 1x 50mL HRP Sample Diluent
6. 1x 25mL HRP Wash Concentrate, 40x concentrate
7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA
8. 1x 10mL TMB Chromogen
9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
51004 | Helicobacter pylori immunoglobulin A (IgA) antibody 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 immunoglobulin A (IgA) antibodies to Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LYR | Helicobacter Pylori |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K024334 | 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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No Device Sizes |
Device Record Status
893e6723-80cc-46cb-955a-dfabbd6135ae
July 06, 2018
3
August 31, 2016
July 06, 2018
3
August 31, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-545-9495
support@inovadx.com
support@inovadx.com