DEVICE: Serum Control Bi-Level (04250317504234)
Device Identifier (DI) Information
Serum Control Bi-Level
0025
In Commercial Distribution
0025
Chromsystems Instruments + Chemicals GmbH
0025
In Commercial Distribution
0025
Chromsystems Instruments + Chemicals GmbH
Serum Control Bi-Level, ß-Carotene in serum/plasma
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? |
---|---|---|---|---|
54438 | Vitamin A IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of vitamin A 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 |
---|
Storage Environment Temperature: less than -18 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 2 x 5 x 2ml |
Device Record Status
8bc0ae70-0afe-49a5-9d82-198db4efc9e8
August 05, 2022
2
July 30, 2020
August 05, 2022
2
July 30, 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
[?]
+4989189300
mailbox@chromsystems.de
mailbox@chromsystems.de