AccessGUDID - DEVICE: EliA IgM Curve Control Strip (07333066012988)

GUDID

Device Identifier (DI) Information

Brand Name: EliA IgM Curve Control Strip
Version or Model: 83-0006-31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83-0006-31
Company Name: Phadia AB

Primary DI Number: 07333066012988
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354019424 *Terms of Use

Device Description: EliA IgM Curve Control Strip

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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
Total immunoglobulin M (IgM total) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using an enzyme immunoassay (EIA) method.

FDA Product Code

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Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091845	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 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: 94d0af64-c4c7-433e-93b8-4eb7ae7a0664
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016