DEVICE: FRUC (05055273208726)

Download: XML | JSON

Device Identifier (DI) Information

FRUC
FR3133
FR3133
RANDOX LABORATORIES LIMITED
05055273208726
GS1
1
Enzymatic assay for the quantitative in vitro determination of glycated protein (fructosamine) in human serum or plasma.
CLOSE

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
Fructosamine 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 the glycated serum protein fructosamine in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LCP Assay, Glycosylated Hemoglobin
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 24, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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