DEVICE: BUS 250 V P F CHLA (B800BUS250VPFCHLA0)
Device Identifier (DI) Information
BUS 250 V P F CHLA
BUS 250 V P F CHLA
In Commercial Distribution
BUS 250 V P F CHLA
UTAK LABORATORIES, INC.
BUS 250 V P F CHLA
In Commercial Distribution
BUS 250 V P F CHLA
UTAK LABORATORIES, INC.
BUS 250 V P F CHLA
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? |
---|---|---|---|---|
47869 | Multiple-type clinical chemistry analyte profile 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 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LAS | Drug Specific Control Materials |
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 -10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 5 Milliliter |
Device Record Status
595dc09a-92a4-4ee8-8f4c-9766c055ce50
December 19, 2023
2
November 27, 2023
December 19, 2023
2
November 27, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B800BUS250VPFCHLA5 | 10 | B800BUS250VPFCHLA0 | In Commercial Distribution | BOX | |
B800BUS250VPFCHLA55 | 5 | B800BUS250VPFCHLA0 | In Commercial Distribution | Box |
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
[?]
1-888-882-5522
welovecontrol@utak.com
welovecontrol@utak.com