DEVICE: FITC Anti-IgA Primary Antibody (04015630971503)
Device Identifier (DI) Information
FITC Anti-IgA Primary Antibody
05267927001
In Commercial Distribution
05267927001
Ventana Medical Systems, Inc.
05267927001
In Commercial Distribution
05267927001
Ventana Medical Systems, Inc.
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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43486 | Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD |
One or multiple immunoglobulins sourced from an animal (e.g., goat, sheep, mouse, rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin A (IgA) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS |
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
963097b1-4ccb-4715-81c7-09cd5d4c121f
July 08, 2025
2
December 07, 2022
July 08, 2025
2
December 07, 2022
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
[?]
No Customer Contact currently defined