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CT hTSH 1000 Tube Kit

FDA UDI

Class II (US FDA UDI)

by Mp Biomedicals, Llc

Identity

Trade Name
CT hTSH 1000 Tube Kit FDA UDI
Generic Name
Thyroid stimulating hormone (TSH) IVD, kit, radioimmunoassay FDA UDI
Device Name
For the quantitative determination of TSH in Serum or Plasma. FDA UDI
Model / Reference
07-294106 FDA UDI
Description
For the quantitative determination of TSH in Serum or Plasma. FDA UDI

Identifiers

Catalog Number
07-294106 FDA UDI
Primary DI / UDI-DI
00817830022580 FDA UDI
510(k) Number
K865071 FDA UDI
FDA Product Code
JLW FDA UDI
GMDN Term
Thyroid stimulating hormone (TSH) IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1690 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 — 43.18 Centimeter FDA UDI

Category: Thyroid stimulating hormone (TSH) IVD, kit, radioimmunoassay

CT hTSH 1000 Tube Kit by Mp Biomedicals, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroid stimulating hormone (TSH) IVD, kit, radioimmunoassay.

Cleared under the same submission

K865071 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 728f811b-9f69-43ce-8050-c334d06cec3d 38 fields · synced May 29, 2026