DEVICE: Fe (05055273206210)

Device Identifier (DI) Information

Fe
SI3821
In Commercial Distribution
SI3821
RANDOX LABORATORIES LIMITED
05055273206210
GS1

1
227530649 *Terms of Use
The product is intended for the quantitative in vitro determination of Iron 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
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of unsaturated iron binding capacity (UIBC) of a clinical specimen, using a spectrophotometry method. UIBC is typically determined by measuring the available capacity of the transport protein transferrin to bind free iron.
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FDA Product Code

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Product Code Product Code Name
JMO Ferrozine (Colorimetric) Iron Binding Capacity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K974604 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 15 and 25 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

78d3b0ac-7af9-4851-bb0a-ba7774dac6b9
July 06, 2018
3
September 16, 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

[?]
+442894451070
technical.services@randox.com
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