AccessGUDID - DEVICE: ALB (05055273200041)

GUDID

Device Identifier (DI) Information

Brand Name: ALB
Version or Model: AB362
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AB362
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273200041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53599	Albumin 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 albumin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIX	Bromcresol Green Dye-Binding, Albumin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984494	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6064fc3c-df5e-4b2b-8a55-5077bc3d506c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016