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MP Biomedicals LLC

FDA UDI

Class I (US FDA UDI)

by Mp Biomedicals, Llc

Identity

Trade Name
MP Biomedicals LLC FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay FDA UDI
Device Name
IMMUCHEM COATED TUBE 17ß-ESTRADIOL 125I RIA 100 TUBE KIT FDA UDI
Model / Reference
07238102 FDA UDI
Description
IMMUCHEM COATED TUBE 17ß-ESTRADIOL 125I RIA 100 TUBE KIT FDA UDI

Identifiers

Catalog Number
07238102 FDA UDI
Primary DI / UDI-DI
00817830023051 FDA UDI
510(k) Number
K791652 FDA UDI
FDA Product Code
CHP FDA UDI
GMDN Term
Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay 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

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

No

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, radioimmunoassay

MP Biomedicals LLC by Mp Biomedicals, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay.

Cleared under the same submission

K791652 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mp Biomedicals, Llc

Sources (1)

  • FDA UDI 772a0c6e-e34d-49b4-9ab6-879c991cf057 35 fields · synced May 30, 2026