DEVICE: H SOLN (05055273214345)
Device Identifier (DI) Information
H SOLN
RX4046
In Commercial Distribution
RX4046
RANDOX LABORATORIES LIMITED
RX4046
In Commercial Distribution
RX4046
RANDOX LABORATORIES LIMITED
Used as a Calibrator in a two-point calibration. H Solution is aspirated from a sample cup located in a pre-registered position on the sample carousel.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
47868 | Multiple-type clinical chemistry analyte profile IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131554 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Special Storage Condition, Specify: Once opened H Solution is stable for 1 month at +15 to +25°C |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
433b6e69-694e-4dd8-9b0d-0709977083ce
December 21, 2020
4
September 26, 2016
December 21, 2020
4
September 26, 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 |
---|---|
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
[?]
+44289445170
technical.services@randox.com
technical.services@randox.com