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Architect

FDA UDI

Class I (US FDA UDI)

by Abbott Ireland

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, calibrator FDA UDI
Device Name
ARCHITECT Estradiol Calibrators FDA UDI
Model / Reference
7K72-01 FDA UDI
Description
ARCHITECT Estradiol Calibrators FDA UDI

Identifiers

Catalog Number
07K7201 FDA UDI
Primary DI / UDI-DI
00380740014681 FDA UDI
FDA Product Code
JJX FDA UDI
JIT FDA UDI
GMDN Term
Estradiol (oestradiol) (E2) IVD, calibrator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
862.1150 FDA UDI
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

No

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, calibrator

The ARCHITECT Estradiol Calibrators device is a medical device designed for quantitative measurement of estradiol (oestradiol) hormone in clinical specimens. It provides calibrated controls for clinical chemistry assays.

Similar devices

Also classified as Estradiol (oestradiol) (E2) IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Ireland

Sources (1)

  • FDA UDI 3289d8be-7094-4fd2-8795-9ebc5d598a72 36 fields · synced Jun 29, 2026