DEVICE: Xpert Factor II & Factor V (07332940000240)

Device Identifier (DI) Information

Xpert Factor II & Factor V
GXFIIFV-10
In Commercial Distribution
GXFIIFV-10
CEPHEID
07332940000240
GS1

1
956711444 *Terms of Use
Xpert Factor II & Factor V kit; 10 test kit
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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
Inherited thrombophilia IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT).
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FDA Product Code

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Product Code Product Code Name
NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K082118 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 28 Degrees Celsius
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Clinically Relevant Size

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

a6dd79d5-86d6-4e59-93ea-33cd66a5db48
July 06, 2018
3
January 29, 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

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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

[?]
1888 838 3222
techsupport@cepheid.com
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