AccessGUDID - DEVICE: IgE CAL SET (05055273203912)

GUDID

Device Identifier (DI) Information

Brand Name: IgE CAL SET
Version or Model: IE2492
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IE2492
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273203912
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.

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

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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
Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of immunoglobulin E (IgE) antibodies to multiple specific protein allergens and/or total immunoglobulin E (IgE total) in a clinical specimen.

FDA Product Code

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Product Code	Product Code Name
DGC	Ige, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010855	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

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Storage and Handling
Special Storage Condition, Specify: After reconstitution, the material is stable for 4 weeks at +2°C to +8°C.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 647d1d8a-f790-4e63-9c40-04fd17effcd4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016