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QUANTA Lite® Calprotectin ELISA

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® Calprotectin ELISA FDA UDI
Generic Name
Calprotectin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Substrate: 1 x15 ml vial. 4. Washing solution (20x): 1x50mL vial. 5. Dilution solution (10x): 1 x20mL vial. 6. Extraction solution (2.5x): 2x50 mL vials. 7. Calibrators: 6 vials containing 1.0 ml Calprotectin at six known concentrations (6.25, 12.5, 25, 50, 100 and 200 ng/ml). 8. Control 1: 1x1.0 mL vial. 9. Control 2: 1x1.0 mL vial. FDA UDI
Model / Reference
704770 FDA UDI
Description
1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Substrate: 1 x15 ml vial. 4. Washing solution (20x): 1x50mL vial. 5. Dilution solution (10x): 1 x20mL vial. 6. Extraction solution (2.5x): 2x50 mL vials. 7. Calibrators: 6 vials containing 1.0 ml Calprotectin at six known concentrations (6.25, 12.5, 25, 50, 100 and 200 ng/ml). 8. Control 1: 1x1.0 mL vial. 9. Control 2: 1x1.0 mL vial. FDA UDI

Identifiers

Primary DI / UDI-DI
08426950657484 FDA UDI
510(k) Number
K191589 FDA UDI
FDA Product Code
NXO FDA UDI
GMDN Term
Calprotectin 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Calprotectin IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Calprotectin IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA UDI 98ec0e11-6cb3-421a-aed9-b65b016b64a3 36 fields · synced Jun 1, 2026