Procise ADL

Primary DI
08100322954301
Brand
Procise ADL
Company
Chembio Diagnostic Systems Inc.
Model
5430
Device description
The Procise ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer.Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab. The test is intended for use in a clinical laboratory.
Published
2024-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QYDAdalimumab Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYDAdalimumab AssayClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08100322954301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08100322954301081003229543018100322954301

GMDN Terms#

Term, Definition table
TermDefinition
TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic drug monitoring of a tumour necrosis factor-alpha (TNF-alpha) inhibitor (e.g., infliximab, adalimumab, golimumab and etanercept) in a clinical specimen, using a fluorescent immunoassay method. The assay is typically used to monitor blood levels of anti-TNF-alpha therapeutics in the treatment of autoimmune conditions such as Crohn's disease, ulcerative colitis and rheumatoid arthritis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160348470
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08100322953854Procise IFX53852024-08-16
08100322954295ProciseDx Calibration Cartridge54292024-08-06
08100322943909ProciseDx Analyzer43902024-08-05
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