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Calprotectin Immunoturbidimetric Assay - Calibrators

FDA UDI

Class II (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name
Calprotectin Immunoturbidimetric Assay - Calibrators FDA UDI
Generic Name
Calprotectin IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
The Calprotectin Immunoturbidimetric Assay - Calibrators is an accessory used in conjunction with the Calprotectin Immunoturbidimetric Assay (80-CALPHU-IT200) by trained laboratory personnel. FDA UDI
Model / Reference
80-CALPHU-ITCAL FDA UDI
Description
The Calprotectin Immunoturbidimetric Assay - Calibrators 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-ITCAL FDA UDI
Primary DI / UDI-DI
B24280CALPHUITCAL0 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

Calprotectin Immunoturbidimetric Assay - Calibrators by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID

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 175b1ac5-5ae0-4026-87e4-b4851bc19d90 37 fields · synced Jun 6, 2026