DEVICE: QUANTA Lite® PBC Screen IgG/IgA ELISA (08426950594239)
Device Identifier (DI) Information
QUANTA Lite® PBC Screen IgG/IgA ELISA
704560
In Commercial Distribution
INOVA DIAGNOSTICS, INC.
704560
In Commercial Distribution
INOVA DIAGNOSTICS, INC.
1. 1x PBC Screen IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder
2. 1x 1.2mL prediluted ELISA Negative Control
3. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA Low Positive
4. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA High Positive
5. 1x 50mL HRP Sample Diluent
6. 1x 25mL HRP Wash Concentrate, 40x concentrate
7. 1x 10mL HRP PBC Screen IgG/IgA Conjugate, (goat), anti-human IgG/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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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? |
---|---|---|---|---|
54830 | Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with liver disease in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at liver-kidney microsome 1 protein (anti-LKM1), smooth muscle (anti-SMA), F-Actin, soluble liver antigen (SLA), Sp-100 protein, glycoprotein-210 (gp210), lamin B receptor (LBR) and also liver cytosol specific antibody type 1 (anti-LC1) and/or antimitochondrial antibodies (AMA).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NUM | Autoantibodies, Nuclear Body Protein, Sp100 |
NRI | Autoantibodies, Nuclear Pore Glycoprotein Gp210 |
DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061842 | 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
e36e14a2-6bf2-49b0-b355-4ed60823f1ef
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