DEVICE: Clarisse (00808829111903)
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? |
|---|---|---|---|---|
| 43774 | Human chorionic gonadotropin alpha-subunit IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of alpha-subunit human chorionic gonadotropin (alpha-HCG) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K123050 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
548227ae-eebf-4a0a-af0b-4cc4abd041ca
July 06, 2023
4
November 17, 2017
July 06, 2023
4
November 17, 2017
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:
00808829113358
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined