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.
70845357041370
GS1

1
060467826 *Terms of Use
Cepheid Xpert® C. difficile/Epi Control Panel
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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
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FDA Product Code

[?]
Product Code Product Code Name
PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K190463 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

cb5e6e3c-7dfd-46c0-98e3-8ec0953fc5e5
August 16, 2019
2
May 31, 2019
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1 (320) 253-7400
techsupport@microbiologics.com
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