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Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]

FDA UDI

Class II (US FDA UDI)

by Biomerica, Inc.

Identity

Trade Name
Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] FDA UDI
Generic Name
Calcitonin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use. FDA UDI
Model / Reference
7024 FDA UDI
Description
The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use. FDA UDI

Identifiers

Primary DI / UDI-DI
08305900070248 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] by Biomerica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K982491 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerica, Inc.

Sources (1)

  • FDA UDI 7aefee90-652d-48fe-b50e-3ae61b8ffd7d 36 fields · synced Jun 6, 2026