AccessGUDID - DEVICE: IMMULITE®2000 Systems 3gAllergy™ nBet v 1 (00630414988122)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE®2000 Systems 3gAllergy™ nBet v 1
Version or Model: 10368597
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A89L2
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414988122
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: Native Bet v 1-Specific IgE - IMMULITE - RGT

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):	Yes
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?
53782	Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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 [?]
K112523	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: e59e2bd8-9420-4304-869a-6fec0419759c
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016