DEVICE: ELVIS (30014613333050)

Device Identifier (DI) Information

ELVIS
55-2412S
In Commercial Distribution
55-2412S
DIAGNOSTIC HYBRIDS, INC.
30014613333050
GS1

1
117359612 *Terms of Use
ELVIS MWP W24/12F W/CS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

09bd6bfd-5c20-45da-8a97-21652a6236a9
September 07, 2018
1
August 07, 2018
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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(858)552-1100
technicalsupport@quidel.com
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