← Back to catalogue

Calcitonin ELISA

FDA UDI

Class II (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name
Calcitonin ELISA FDA UDI
Generic Name
Calcitonin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The Calcitonin ELISA is intended for use in the quantitative determination of Calcitonin in human serum. FDA UDI
Model / Reference
21-CALHU-E01 FDA UDI
Description
The Calcitonin ELISA is intended for use in the quantitative determination of Calcitonin in human serum. FDA UDI

Identifiers

Catalog Number
21-CALHU-E01 FDA UDI
Primary DI / UDI-DI
B24221CALHUE010 FDA UDI
510(k) Number
K982491 FDA UDI
FDA Product Code
JKR FDA UDI
GMDN Term
Calcitonin IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1140 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: Calcitonin IVD, kit, enzyme immunoassay (EIA)

Calcitonin ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K982491 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
American Laboratory Products Company

Sources (1)

  • FDA UDI 548ced1d-ea94-43a5-a3fb-79635d379c87 37 fields · synced May 30, 2026