DEVICE: Cytomegalovirus (CMV) (00847627038616)
Device Identifier (DI) Information
Cytomegalovirus (CMV)
NPAA118T40
In Commercial Distribution
BIOCARE MEDICAL LLC
NPAA118T40
In Commercial Distribution
BIOCARE MEDICAL LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
62756 | Cytomegalovirus (CMV) antigen IVD, antibody |
One or multiple immunoglobulins with the capability of binding to specific antigenic determinants intended to be used for the qualitative and/or quantitative detection of antigens from Cytomegalovirus (CMV) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVU | Reagents, Specific, Analyte |
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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bf45fd53-0da5-49f1-8ba7-fa1288e732e1
April 21, 2025
1
April 11, 2025
April 21, 2025
1
April 11, 2025
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
[?]
No Customer Contact currently defined