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IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers

FDA UDI

Class I (US FDA UDI)

by Immunodiagnostic Systems , Ltd.

Identity

Trade Name
IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers FDA UDI
Generic Name
Collagen type I cross-linked C-telopeptide IVD, calibrator FDA UDI
Model / Reference
IS-3035 FDA UDI

Identifiers

Primary DI / UDI-DI
05060169690943 FDA UDI
510(k) Number
K111650 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Collagen type I cross-linked C-telopeptide IVD, calibrator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

Category: Collagen type I cross-linked C-telopeptide IVD, calibrator

IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers by Immunodiagnostic Systems , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Collagen type I cross-linked C-telopeptide IVD, calibrator.

Cleared under the same submission

K111650 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immunodiagnostic Systems , Ltd.

Sources (1)

  • FDA UDI 39eb38b9-bdcd-4769-bd3a-e28759e9ac22 35 fields · synced May 30, 2026