DEVICE: VLGR LEVEL 3 (B80002509000070)
Device Identifier (DI) Information
VLGR LEVEL 3
VLGR 3 S F MAYO
In Commercial Distribution
UTAK LABORATORIES, INC.
VLGR 3 S F MAYO
In Commercial Distribution
UTAK LABORATORIES, INC.
No description.
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? |
---|---|---|---|---|
55235 | Multiple-therapy therapeutic drug monitoring IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.
|
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1a46e117-023a-4568-992b-73f726d442b0
May 11, 2022
1
May 03, 2022
May 11, 2022
1
May 03, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B80002509000071 | 4 | B80002509000070 | In Commercial Distribution | Box | |
B80002509000072 | 5 | B80002509000070 | In Commercial Distribution | Box | |
B80002509000073 | 10 | B80002509000070 | In Commercial Distribution | Box | |
B80002509000076 | 25 | B80002509000070 | In Commercial Distribution | Box | |
B80002509000077 | 50 | B80002509000070 | In Commercial Distribution | Box | |
B80002509000078 | 100 | B80002509000070 | In Commercial Distribution | Box | |
B80002509000079 | 81 | B80002509000070 | 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