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Free T4 MAb 125I RIA Kit

FDA UDI

Class II (US FDA UDI)

by Mp Biomedicals, Llc

Identity

Trade Name
Free T4 MAb 125I RIA Kit FDA UDI
Generic Name
Free thyroxine (FT4) IVD, kit, radioimmunoassay FDA UDI
Device Name
Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in human plasma or serum. FDA UDI
Model / Reference
06B257214 FDA UDI
Description
Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in human plasma or serum. FDA UDI

Identifiers

Catalog Number
06B257214 FDA UDI
Primary DI / UDI-DI
00817830022498 FDA UDI
510(k) Number
K823264 FDA UDI
FDA Product Code
CEC FDA UDI
GMDN Term
Free thyroxine (FT4) IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1695 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 28 Centimeter FDA UDI

Category: Free thyroxine (FT4) IVD, kit, radioimmunoassay

Free T4 MAb 125I RIA Kit by Mp Biomedicals, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Free thyroxine (FT4) IVD, kit, radioimmunoassay.

Cleared under the same submission

K823264 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 1f9f6c36-0651-4fc6-9b69-6407e15abb72 38 fields · synced May 30, 2026