AccessGUDID - DEVICE: QUANTA LITE®Calprotectin Extended Range (08426950913337)

GUDID

Device Identifier (DI) Information

Brand Name: QUANTA LITE®Calprotectin Extended Range
Version or Model: 704860
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08426950913337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: 1. Antibody coated plate 12x8 wells coated with antibody against calprotectin. Plastic sealed bag containing a desiccant. 2. Enzyme conjugate antibody (IgG) 1 vial containing 15 ml Horse-radish peroxidase-labeled rabbit anti-human calprotectin IgG antibodies in a buffer solution with Proclin 300 as a preservative. Ready-to-use. 3. Substrate 1 vial containing 15 ml substrate reagent (TMB). Ready-to-use 4. Stop Solution 1 vial containing 15 ml H2SO4 (0.5M). Ready-to-use 5. Washing solution (20x) 1 vial containing 50 ml concentrated washing solution. To be diluted with distilled water. 6. Diluent solution (10x) 1 vial containing 20 ml concentrated diluent solution to be diluted with distilled water. 7. Extraction solution (2.5x) 2 vials containing 100 ml concentrated extraction solution to be diluted with distilled water. This concentrated solution is irritating to eyes and skin. 8. Calibrators 6 vials containing 1.5 ml Calprotectin solution at six known concentrations (0, 2.5, 12.5, 25, 50, 150 ng/ml). The value of each Calibrator is printed on the vial label. Ready-to-use. 9. Control 1 1 vial containing 1.5 ml of control 1. Ready-to-use. Do not dilute. The range of values is printed on the vial label. 10. Control 2 1 vial containing 1.5 ml of control 2. Ready-to-use. Do not dilute. The range of values is printed on the vial label.

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?
52862	Multiple gastrointestinal disease marker 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 one or multiple antigens or markers associated with gastrointestinal disease in a clinical specimen, using an enzyme immunoassay (EIA) method. Markers to be assayed may include pepsinogen I, pepsinogen II, gastrin and/or antibodies to the bacteria Helicobacter pylori.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXO	Calprotectin, Fecal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191592	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: 2cc97900-7e7a-4a0b-b06f-5de40a55c583
Public Version Date: August 21, 2020
Public Version Number: 4
DI Record Publish Date: December 15, 2016