DEVICE: APO B (05055273204346)

Device Identifier (DI) Information

APO B
LP2117
In Commercial Distribution
LP2117
RANDOX LABORATORIES LIMITED
05055273204346
GS1

1
227530649 *Terms of Use
An APO B test system is a device intended for the quantitative in vitro determination of Apolipoprotein B (APO B) in serum and plasma.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry A collection of reagents and other associated materials intended to be used for the quantitative measurement of apolipoprotein B (Apo B) lipid in a clinical specimen, using a nephelometry/turbidimetry method.
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FDA Product Code

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Product Code Product Code Name
JHN Turbidimetric Method, Lipoproteins
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K950383 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e139e03a-ad01-48ff-8ac8-c4883b370f4e
July 06, 2018
3
September 26, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+442894451070
technical.services@randox.com
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