AccessGUDID - DEVICE: IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3) (00630414963655)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3)
Version or Model: 10380948
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LKBR1
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414963655
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: CA 15-3 - 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?
60975	Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOI	SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013984	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: f8ad9458-8935-443c-abc5-ef35c8119c86
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016