DEVICE: ARCHITECT (00380740096137)
Device Identifier (DI) Information
ARCHITECT
5P03-01
In Commercial Distribution
05P0301
Abbott GmbH
5P03-01
In Commercial Distribution
05P0301
Abbott GmbH
ARCHITECT Galectin-3 Calibrators
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? |
---|---|---|---|---|
48150 | Galectin-3 IVD, calibrator |
A material which is used to establish known points of reference for an assay that is intended to be used for the qualitative and/or quantitative detection of galectin-3 protein in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIT | CALIBRATOR, SECONDARY |
OSX | Galectin-3 in vitro diagnostic assay |
JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K140436 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: less than 29 Degrees Celsius |
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
4aaf900b-c6e4-498e-9377-be1d2dd82085
February 21, 2024
6
September 09, 2016
February 21, 2024
6
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 |
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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
[?]
+1(877)422-2688
xx@xx.xx
xx@xx.xx