DEVICE: EliA Sample Diluent (07333066012872)

Device Identifier (DI) Information

EliA Sample Diluent
83-0003-71
In Commercial Distribution
83-0003-71
Phadia AB
07333066012872
GS1

1
354019424 *Terms of Use
EliA Sample Diluent
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Plasma protein IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of plasma proteins in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
NHX ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K061165 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 8 Degrees Celsius
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Clinically Relevant Size

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

1feb7389-84b3-4770-a399-9253f85e0153
July 06, 2018
3
September 23, 2016
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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
07333066013800 6 07333066012872 In Commercial Distribution
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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

[?]
+469999999999
xx@xx.xx
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