AccessGUDID - DEVICE: IMMULITE® 2000 Systems SPE 3gAllergy Specific IgE Sample Diluent (00630414953496)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® 2000 Systems SPE 3gAllergy Specific IgE Sample Diluent
Version or Model: 10283033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L2UNZ
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414953496
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: 3G Allergy Sample Diluent - IMMULITE - CAL - 1x25mL

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?
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	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 [?]
K093107	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: 0fbb300d-d593-4302-acb8-a7e10f502e0a
Public Version Date: June 02, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016