AccessGUDID - DEVICE: Crosslaps Serum ELISA (04048474021240)

GUDID

Device Identifier (DI) Information

Brand Name: Crosslaps Serum ELISA
Version or Model: EIA-2124
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-2124
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 04048474021240
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47421	Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of collagen type I cross-linked C-telopeptides in a clinical specimen, using an enzyme immunoassay (EIA) method. Collagen type I cross-linked C-telopeptide is a biomarker for bone turnover and elevated levels are associated with conditions of increased bone lysis (e.g., multiple myeloma, osteolytic metastases, and rheumatoid arthritis).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111650	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1930548c-945a-41ef-9308-e40e67d47116
Public Version Date: September 06, 2023
Public Version Number: 1
DI Record Publish Date: August 29, 2023