QUANTA LITE®Calprotectin Extended Range

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name: QUANTA LITE®Calprotectin Extended Range FDA UDI
Generic Name: Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 704860 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 08426950913337 FDA UDI
510(k) Number: K191592 FDA UDI
FDA Product Code: NXO FDA UDI
GMDN Term: Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5180 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)

QUANTA LITE®Calprotectin Extended Range by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Inova Diagnostics, Inc.

Sources (1)

FDA UDI 2cc97900-7e7a-4a0b-b06f-5de40a55c583 36 fields · synced May 30, 2026