DEVICE: QC Sets and Panels: Helix Elite™ (70845357041370)
Device Identifier (DI) Information
QC Sets and Panels: Helix Elite™
8200 Cepheid Xpert® C. difficile/Epi Control Panel
In Commercial Distribution
8200
MICROBIOLOGICS INC.
8200 Cepheid Xpert® C. difficile/Epi Control Panel
In Commercial Distribution
8200
MICROBIOLOGICS INC.
Cepheid Xpert® C. difficile/Epi Control Panel
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? |
---|---|---|---|---|
50838 | Clostridium difficile nucleic acid IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] in a clinical specimen and/or culture isolate.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K190463 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
cb5e6e3c-7dfd-46c0-98e3-8ec0953fc5e5
August 16, 2019
2
May 31, 2019
August 16, 2019
2
May 31, 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 |
---|---|---|---|---|---|
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 (320) 253-7400
techsupport@microbiologics.com
techsupport@microbiologics.com