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Salivary Estradiol HS ELISA

FDA UDI

Class I (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
Salivary Estradiol HS ELISA FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The DRG Salivary Estradiol HS ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free estradiol in saliva. Results may be used to assess fertility problems in women; to diagnose menopause, and to monitor hormone replacement therapy. FDA UDI
Model / Reference
SLV-6145 FDA UDI
Description
The DRG Salivary Estradiol HS ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free estradiol in saliva. Results may be used to assess fertility problems in women; to diagnose menopause, and to monitor hormone replacement therapy. FDA UDI

Identifiers

Catalog Number
SLV-6145 FDA UDI
Primary DI / UDI-DI
00840239061454 FDA UDI
FDA Product Code
CHP FDA UDI
GMDN Term
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1260 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: Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Estradiol (oestradiol) (E2) 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 abb1cbaf-3ea3-464d-a743-4972e92fd5f1 36 fields · synced May 30, 2026