AccessGUDID - DEVICE: IMMULITE Systems 3gAllerg Specific IgE Positive Control for M6 (00630414984582)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE Systems 3gAllerg Specific IgE Positive Control for M6
Version or Model: 10485106
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MC6LCM
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414984582
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: Specific IgE M6 - IMMULITE - CTL - 1x4mL

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):	No
Over the Counter (OTC):	No
Kit:	No
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?
41349	Allergen-specific immunoglobulin E (IgE) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical specimen.	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 [?]
K013134	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: 9e4034f5-cbdc-442e-b343-a60333c2ffb1
Public Version Date: June 10, 2022
Public Version Number: 7
DI Record Publish Date: September 24, 2016