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Sebia NTx Serum Test System

FDA UDI

Class I (US FDA UDI)

by Zeus Scientific, Inc.

Identity

Trade Name
Sebia NTx Serum Test System FDA UDI
Generic Name
Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera. FDA UDI
Model / Reference
XJ9021 FDA UDI
Description
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera. FDA UDI

Identifiers

Catalog Number
XJ9021 FDA UDI
Primary DI / UDI-DI
00845533002004 FDA UDI
FDA Product Code
JMM FDA UDI
GMDN Term
Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1400 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

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: Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)

Sebia NTx Serum Test System by Zeus Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI 54f21d3a-d14b-4d7d-9fe6-acc116b4dabb 34 fields · synced May 30, 2026