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Corticosterone ELISA

FDA UDI

Class I (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
Corticosterone ELISA FDA UDI
Generic Name
Corticosterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The DRG Corticosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of corticosterone in serum or plasma (lithium heparin or citrate plasma). FDA UDI
Model / Reference
EIA-4164 FDA UDI
Description
The DRG Corticosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of corticosterone in serum or plasma (lithium heparin or citrate plasma). FDA UDI

Identifiers

Catalog Number
EIA-4164 FDA UDI
Primary DI / UDI-DI
00840239041647 FDA UDI
FDA Product Code
CHA FDA UDI
GMDN Term
Corticosterone IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1200 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Corticosterone ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG International, Inc.

Sources (1)

  • FDA UDI 43466b9d-c3d3-4c87-a7d4-7b34ded51d38 36 fields · synced Jun 8, 2026