AccessGUDID - DEVICE: BÜHLMANN fCAL® ELISA (EBUHBEKCAL0)

GUDID

Device Identifier (DI) Information

Brand Name: BÜHLMANN fCAL® ELISA
Version or Model: EK-CAL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bühlmann Laboratories AG

Primary DI Number: EBUHBEKCAL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481261006 *Terms of Use

Device Description: Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimens

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):	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?
53624	Calprotectin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of calprotectin protein in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is commonly used to aid in the diagnosis of inflammatory bowel disease or other causes of intestinal inflammation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXO	Calprotectin, Fecal

FDA Premarket Submission

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

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: 35529fec-8c64-4ddd-9b7f-182784fdd321
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: November 06, 2019