DEVICE: VITROS (10758750006816)
Device Identifier (DI) Information
VITROS
6801732
In Commercial Distribution
6801732
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801732
In Commercial Distribution
6801732
ORTHO-CLINICAL DIAGNOSTICS, INC.
VITROS Chemistry Products IgA Reagent
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? |
---|---|---|---|---|
53758 | Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin A (IgA total) in a clinical specimen, using a nephelometry/turbidimetry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
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
61b8fb57-7b53-406f-b8ea-2adbfd1edea8
June 21, 2023
4
August 26, 2016
June 21, 2023
4
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 |
---|---|---|---|---|---|
20758750006813 | 36 | 10758750006816 | 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