AccessGUDID - DEVICE: ImmunoCAP Specific IgE Calibrators 0-100 (07333066019659)

GUDID

Device Identifier (DI) Information

Brand Name: ImmunoCAP Specific IgE Calibrators 0-100
Version or Model: 10-9460-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-9460-01
Company Name: Phadia AB

Primary DI Number: 07333066019659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354019424 *Terms of Use

Device Description: Contains one vial of each Specific IgE Calibrator (Cal-0, Cal-0.35, Cal-0.7, Cal-3.5, Cal-17.5, Cal-100) to form a complete calibration curve for the ImmunoCAP Specific IgE method.

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?
53781	Allergen-specific immunoglobulin E (IgE) antibody 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 immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to screen for allergies associated with certain conditions (e.g., food intolerance).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DHB	System, test, radioallergosorbent (rast) immunological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051218	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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c08deffe-b237-4671-b56d-6ef22145980a
Public Version Date: August 03, 2023
Public Version Number: 3
DI Record Publish Date: March 26, 2019