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Elecsys Beta-CrossLaps/serum

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys Beta-CrossLaps/serum FDA UDI
Generic Name
Collagen type I cross-linked C-telopeptide IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
09005773160 FDA UDI

Identifiers

Catalog Number
09005773160 FDA UDI
Primary DI / UDI-DI
07613336187012 FDA UDI
FDA Product Code
JMM FDA UDI
GMDN Term
Collagen type I cross-linked C-telopeptide IVD, kit, chemiluminescent immunoassay 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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 C-telopeptide IVD, kit, chemiluminescent immunoassay

Elecsys Beta-CrossLaps/serum by Roche Diagnostics Corp. — 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, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI 86bde120-cf2a-4d2f-abca-b8ed692d62fd 33 fields · synced May 31, 2026