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Pointe Scientific Estradiol

FDA UDI

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific Estradiol FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Estradiol EIA Kit is for the quantitative determination of estradiol (E2) concentration in human serum. For in vitro diagnostic use only. 96 tests FDA UDI
Model / Reference
S1111-96 FDA UDI
Description
Estradiol EIA Kit is for the quantitative determination of estradiol (E2) concentration in human serum. For in vitro diagnostic use only. 96 tests FDA UDI

Identifiers

Catalog Number
S1111-96 FDA UDI
Primary DI / UDI-DI
00811727013286 FDA UDI
GMDN Term
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Commercial Distribution
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

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

No

FDA UDI

Category: Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

Pointe Scientific Estradiol by Pointe Scientific, Inc. — 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
Pointe Scientific, Inc.

Sources (1)

  • FDA UDI 62d6a7c9-8c16-4758-ab2f-f828129084d6 36 fields · synced Jun 8, 2026