DEVICE: ARCHITECT (00380740156435)
Device Identifier (DI) Information
ARCHITECT
07K0041
In Commercial Distribution
07K0041
ABBOTT LABORATORIES
07K0041
In Commercial Distribution
07K0041
ABBOTT LABORATORIES
Quantia Lipoprotein(a)
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
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? |
---|---|---|---|---|
53438 | Lipoprotein A IVD, kit, nephelometry/turbidimetry |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DFC | LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL |
JJX | Single (specified) analyte controls (assayed and unassayed) |
JIS | Calibrator, primary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K050487 | 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
97ebcca3-0169-4db3-ab23-916016faa9e8
September 04, 2023
3
March 03, 2020
September 04, 2023
3
March 03, 2020
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