DEVICE: Xpert EV (07332940000097)
Device Identifier (DI) Information
Xpert EV
GXEV-100N-10
In Commercial Distribution
GXEV-100N-10
CEPHEID
GXEV-100N-10
In Commercial Distribution
GXEV-100N-10
CEPHEID
Xpert EV kit; 10 test kit
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? |
---|---|---|---|---|
61043 | Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of pathogens associated with meningitis, in a clinical specimen, using a nucleic acid technique (NAT). Pathogens detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2), varicella-zoster virus (VZV), and Mumps virus.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OAI | Assay, Enterovirus Nucleic Acid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
DEN070004 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 28 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
79a234fa-e00b-408f-9378-2c85b16c4652
December 21, 2020
5
January 29, 2018
December 21, 2020
5
January 29, 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
[?]
1 888 838 3222
techsupport@cepheid.com
techsupport@cepheid.com