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Epredia

FDA UDI

Class I (US FDA UDI)

by Richard-Allan Scientific LLC

Identity

Trade Name
Epredia FDA UDI
Generic Name
Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
Progesterone Recept. [YR85] ASR FDA UDI
Model / Reference
RM-2114-S0-A FDA UDI
Description
Progesterone Recept. [YR85] ASR FDA UDI

Identifiers

Primary DI / UDI-DI
00673693658959 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1860 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry

Epredia by Richard-Allan Scientific LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Richard-Allan Scientific LLC

Sources (1)

  • FDA UDI 091f187a-ac29-4994-88a6-19a191d0f08f 33 fields · synced Jun 8, 2026