Estrone Serum ELISA

FDA UDI

Class I (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name: Estrone Serum ELISA FDA UDI
Generic Name: Centrifuge tube IVD FDA UDI
Device Name: For the quantitative determination of Estrone in human saliva by a chemiluminescence immunoassay. FDA UDI
Model / Reference: CLA-4654 FDA UDI
Description: For the quantitative determination of Estrone in human saliva by a chemiluminescence immunoassay. FDA UDI

Identifiers

Catalog Number: CLA-4654 FDA UDI
Primary DI / UDI-DI: 00840239046543 FDA UDI
FDA Product Code: CGF FDA UDI
GMDN Term: Centrifuge tube IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1280 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Centrifuge tube IVD

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: DRG International, Inc.

Sources (1)

FDA UDI ecbe75f3-ae55-434d-ad60-e94c34509f58 36 fields · synced May 30, 2026