DEVICE: ARCHITECT (00380740011185)
Device Identifier (DI) Information
ARCHITECT
6L27-25
In Commercial Distribution
06L2725
Abbott GmbH
6L27-25
In Commercial Distribution
06L2725
Abbott GmbH
ARCHITECT HAVAB-G Reagent Kit
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? |
---|---|---|---|---|
48279 | Hepatitis A virus immunoglobulin G (IgG) 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 immunoglobulin G (IgG) antibodies to the Hepatitis A virus in a clinical specimen, using a chemiluminescent immunoassay method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MJY | KIT, SEROLOGICAL, NEGATIVE CONTROL |
JIS | CALIBRATOR, PRIMARY |
LOL | Hepatitis a test (antibody and igm antibody) |
MJX | KIT, SEROLOGICAL, POSITIVE CONTROL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K113704 | 000 |
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
194576e6-0b30-4315-a0ab-57ad5ed1c3d3
February 21, 2024
5
September 09, 2016
February 21, 2024
5
September 09, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(877)422-2688
xx@xx.xx
xx@xx.xx