← Back to catalogue

ZEUS NTx Serum

FDA UDI

Class I (US FDA UDI)

by Zeus Scientific, Inc.

Identity

Trade Name
ZEUS NTx Serum 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
NTx9021 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
00845533001953 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

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

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)

ZEUS NTx Serum 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI d75816fb-b00e-43f1-bcce-227ec2a96016 34 fields · synced May 30, 2026