DEVICE: VITROS (10758750001477)
Device Identifier (DI) Information
VITROS
6801823
In Commercial Distribution
6801823
ORTHO CLINICAL DIAGNOSTICS
6801823
In Commercial Distribution
6801823
ORTHO CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products HAV Total Reagent Pack
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
48286 | Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis A virus in a clinical specimen, using a chemiluminescent immunoassay method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LOL | Hepatitis a test (antibody and igm antibody) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: Do not freeze |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5538df04-be7f-44ce-8b94-c19b2b30958d
February 19, 2025
5
August 26, 2016
February 19, 2025
5
August 26, 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 |
---|---|---|---|---|---|
20758750001474 | 30 | 10758750001477 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
No Customer Contact currently defined