DEVICE: DRUGS OF ABUSE CAL (B80010029000030)
Device Identifier (DI) Information
DRUGS OF ABUSE CAL
DA CAL M LB
In Commercial Distribution
UTAK LABORATORIES, INC.
DA CAL M LB
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? |
---|---|---|---|---|
30503 | Multiple therapeutic drugs/drugs of abuse 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 therapeutic drugs and drugs of abuse 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
2429257c-b111-4d79-9b17-9944add04309
May 12, 2022
1
May 04, 2022
May 12, 2022
1
May 04, 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 |
---|---|---|---|---|---|
B80010029000031 | 4 | B80010029000030 | In Commercial Distribution | Box | |
B80010029000032 | 5 | B80010029000030 | In Commercial Distribution | Box | |
B80010029000033 | 10 | B80010029000030 | In Commercial Distribution | Box | |
B80010029000036 | 25 | B80010029000030 | In Commercial Distribution | Box | |
B80010029000037 | 50 | B80010029000030 | In Commercial Distribution | Box | |
B80010029000038 | 100 | B80010029000030 | 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