DEVICE: Urine Calibration Standard (04250317543233)
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Device Identifier (DI) Information
Urine Calibration Standard
1009
In Commercial Distribution
1009
Chromsystems Instruments + Chemicals GmbH
1009
In Commercial Distribution
1009
Chromsystems Instruments + Chemicals GmbH
Urine Calibration Standard VMA, HVA, 5-HIAA
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? |
|---|---|---|---|---|
| 60610 | HVA/VMA/5HIAA IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of homovanillic acid (HVA), vanillylmandelic acid (VMA) and 5-hydroxyindoleacetic acid (5HIAA) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JIX | Calibrator, Multi-Analyte Mixture |
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: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 5 x 5ml |
Device Record Status
db978c6d-2c88-4028-a0b6-b68e7e0b1961
April 01, 2019
1
March 22, 2019
April 01, 2019
1
March 22, 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 |
|---|---|---|---|---|---|
| 04250317500434 | 5 | 04250317543233 | In Commercial Distribution |
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