DEVICE: ELVIS (30014613333029)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
30670 | Cell culture line IVD |
A cell line of known origin intended to be used alone or in combination with other IVDs, for cytogenetic analyses and/or for the detection/cultivation of viruses present in clinical laboratory specimens.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GQL | Antisera, fluorescent, herpesvirus hominis 1,2 |
GQN | Antigen, cf (including cf control), herpesvirus hominis 1,2 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K091753 | 000 |
K941924 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
02ce6c03-ac7f-4606-a308-e3dcb7cbc6a3
June 29, 2023
3
August 07, 2018
June 29, 2023
3
August 07, 2018
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(858)552-1100
technicalsupport@quidel.com
technicalsupport@quidel.com