DEVICE: ST AIA-PACK LH II (14560189210698)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
54253 | Luteinizing hormone (LH) 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 luteinizing hormone (LH) in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CEP | Radioimmunoassay, Luteinizing Hormone |
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
48a38dac-bede-4c02-bd9d-cc128ed36b5e
April 01, 2024
3
July 24, 2019
April 01, 2024
3
July 24, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
24560189210695 | 10 | 14560189210698 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04560189210691
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
650-615-8134
Dave.Wurtz@tosoh.com
Dave.Wurtz@tosoh.com