FDA.reportPublic FDA data

Crosslaps Serum ELISA

Primary DI
00840239021243
Brand
Crosslaps Serum ELISA
Company
DRG International Inc
Model
EIA-2124
Catalog number
EIA-2124
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.
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111650000IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...Immunodiagnostic Systems , Ltd.2011-09-06JJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239021243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239021243008402390212438402390212430840239021243

GMDN Terms#

Term, Definition table
TermDefinition
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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9735647555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Kit
true
Manufacturing date on label
true
Expiration date on label
true

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00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
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00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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