AccessGUDID - DEVICE: ALPCO Calprotectin Chemiluminescence ELISA (B24280CALPHUCH500)

GUDID

Device Identifier (DI) Information

Brand Name: ALPCO Calprotectin Chemiluminescence ELISA
Version or Model: 80-CALPHU-CH50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80-CALPHU-CH50
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24280CALPHUCH500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.

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?
62675	Calprotectin IVD, kit, chemiluminescent immunoassay	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 a chemiluminescent immunoassay 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 [?]
K191807	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: 91043053-fc43-4993-ae38-72328d4c9e51
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: November 04, 2019