AccessGUDID - DEVICE: IMMULITE® SBG Control SHBG (00630414998947)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® SBG Control SHBG
Version or Model: 10285226
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSHCM
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414998947
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: SHBG - IMMULITE - CTL - 1x1x2mL

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?
42182	Sex hormone binding globulin (SHBG) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of sex hormone binding globulin (SHBG) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDZ	RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955440	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: bfdc59ab-33dc-4ab7-a6ee-092515a0310f
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016