AccessGUDID - DEVICE: ALPCO Calprotectin Immunoturbidimetric Assay (B24280CALPHUIT100)

GUDID

Device Identifier (DI) Information

Brand Name: ALPCO Calprotectin Immunoturbidimetric Assay
Version or Model: 80-CALPHU-IT100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80-CALPHU-IT100
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24280CALPHUIT100
Issuing Agency: HIBCC
Commercial Distribution End Date: August 25, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in 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?
66395	Calprotectin IVD, kit, nephelometry/turbidimetry	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 nephelometry/turbidimetry 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 [?]
K220763	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: b4f9956b-1931-49a2-a8ef-d8a39d1c8391
Public Version Date: August 25, 2023
Public Version Number: 3
DI Record Publish Date: June 09, 2023