AccessGUDID - DEVICE: STELLUX® Chemi Human Insulin ELISA (B24280INSHUCH010)

GUDID

Device Identifier (DI) Information

Brand Name: STELLUX® Chemi Human Insulin ELISA
Version or Model: 80-INSHU-CH01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80-INSHU-CH01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24280INSHUCH010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
54237	Insulin IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFP	Radioimmunoassay, Immunoreactive Insulin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 0e8a6aab-e1db-4320-983f-535997492fb5
Public Version Date: July 27, 2020
Public Version Number: 1
DI Record Publish Date: July 17, 2020