DEVICE: Pantex (00850039602672)
Device Identifier (DI) Information
Pantex
N/A
In Commercial Distribution
635
Pantex
N/A
In Commercial Distribution
635
Pantex
Salivary Direct Testosterone Enzyme Immunoassay (25 Pack)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
58379 | Total testosterone IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total testosterone in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone |
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: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
103a9d7c-678e-446e-a403-6775be0b949b
May 03, 2023
2
February 17, 2023
May 03, 2023
2
February 17, 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 |
---|---|---|---|---|---|
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
[?]
1-310-828-7423
info@pantexba.com
info@pantexba.com