DEVICE: CELL-DYN (00380740017071)
Device Identifier (DI) Information
CELL-DYN
08H57-01
In Commercial Distribution
08H5701
ABBOTT LABORATORIES
08H57-01
In Commercial Distribution
08H5701
ABBOTT LABORATORIES
CELL-DYN HemCal Plus Calibrator
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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? |
---|---|---|---|---|
55865 | Full blood count 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 determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KRY | CALIBRATOR FOR PLATELET COUNTING |
KRX | CALIBRATOR FOR CELL INDICES |
KSA | CALIBRATOR FOR RED-CELL AND WHITE-CELL COUNTING |
KRZ | CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020469 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2405f097-e3ba-457e-8419-728962cd7182
August 25, 2023
4
June 06, 2016
August 25, 2023
4
June 06, 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
[?]
+1(877)422-2688
xx@xx.xx
xx@xx.xx