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ALPCO Calprotectin Immunoturbidimetric Assay

FDA UDI

Class II (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name
ALPCO Calprotectin Immunoturbidimetric Assay FDA UDI
Generic Name
Calprotectin IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimetric Assay (80-CALPHU-IT200) by trained laboratory personnel. FDA UDI
Model / Reference
80-CALPHU-ITCON FDA UDI
Description
The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimetric Assay (80-CALPHU-IT200) by trained laboratory personnel. FDA UDI

Identifiers

Catalog Number
80-CALPHU-ITCON FDA UDI
Primary DI / UDI-DI
B24280CALPHUITCON0 FDA UDI
510(k) Number
K220763 FDA UDI
FDA Product Code
NXO FDA UDI
GMDN Term
Calprotectin IVD, kit, nephelometry/turbidimetry 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, nephelometry/turbidimetry

ALPCO Calprotectin Immunoturbidimetric Assay by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Calprotectin IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K220763 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Laboratory Products Company

Sources (1)

  • FDA UDI 4e13a5d5-10e7-44ac-a6a2-fbdfc49b979d 37 fields · synced Jun 6, 2026