DEVICE: ADVIA Centaur Androstenedione MCM (00630414603438)
Device Identifier (DI) Information
ADVIA Centaur Androstenedione MCM
10997268
In Commercial Distribution
10997268
Siemens Healthcare Diagnostics Inc.
10997268
In Commercial Distribution
10997268
Siemens Healthcare Diagnostics Inc.
Androstenedione (Andro) ADVIA Centaur - Master Curve Material 5x1x1.0mL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
41780 | Androstenedione IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of androstenedione in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJX | Single (specified) analyte controls (assayed and unassayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store below -20 deg C, Store Upright & Protect from Light |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2b1d651a-9ffe-4a2c-9d07-1883afc3dc66
November 18, 2021
3
October 25, 2019
November 18, 2021
3
October 25, 2019
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)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
CONTACT@SIEMENS-HEALTHINEERS.COM