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Crosslaps Serum ELISA

FDA UDI

Class I (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
Crosslaps Serum ELISA FDA UDI
Generic Name
Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The Crosslaps Serum ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type I collagen in human serum and plasma. FDA UDI
Model / Reference
EIA-2124 FDA UDI
Description
The Crosslaps Serum ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type I collagen in human serum and plasma. FDA UDI

Identifiers

Catalog Number
EIA-2124 FDA UDI
Primary DI / UDI-DI
00840239021243 FDA UDI
510(k) Number
K111650 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Crosslaps Serum ELISA by DRG International, Inc. — 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, enzyme immunoassay (EIA).

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
DRG International, Inc.

Sources (1)

  • FDA UDI f2a4cff9-a233-4b05-a648-737b6ed6c093 37 fields · synced May 30, 2026