DEVICE: NORMAL HUMAN SERUM (B80002509000040)
Device Identifier (DI) Information
NORMAL HUMAN SERUM
44600-S(MAYO)
In Commercial Distribution
UTAK LABORATORIES, INC.
44600-S(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? |
---|---|---|---|---|
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 |
---|
No Device Sizes |
Device Record Status
a67f3507-1523-4679-925c-091624116f15
May 03, 2022
1
April 25, 2022
May 03, 2022
1
April 25, 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 |
---|---|---|---|---|---|
B80002509000041 | 4 | B80002509000040 | In Commercial Distribution | Box | |
B80002509000042 | 5 | B80002509000040 | In Commercial Distribution | Box | |
B80002509000043 | 10 | B80002509000040 | In Commercial Distribution | Box | |
B80002509000046 | 25 | B80002509000040 | In Commercial Distribution | Box | |
B80002509000047 | 50 | B80002509000040 | In Commercial Distribution | Box | |
B80002509000048 | 100 | B80002509000040 | In Commercial Distribution | Box | |
B80002509000049 | 81 | B80002509000040 | 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