AccessGUDID - DEVICE: IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE (00630414966137)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE
Version or Model: 10380867
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LKIE1
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414966137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: IgE - IMMULITE - RGT - 100 Tests

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):	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?
53775	Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JHR	RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960067	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3437c45c-94ba-47ce-8591-ef79a32b0e77
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016