FDA.reportPublic FDA data

5-PLASMA Bivalirudin Calibrator

Primary DI
05070002420392
Brand
5-PLASMA Bivalirudin Calibrator
Company
5-Diagnostics Ltd
Model
5D-46905
Catalog number
5D-46905
Device description
Human plasma-based calibrator material intended for calibration of bivalirudin measurements using anti-IIa clotting and chromogenic assay methods. The product consists of multiple calibration levels and is intended for in vitro diagnostic use by trained laboratory professionals.
Published
2026-04-02
Public version status
Update
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
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05070002420392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05070002420392050700024203925070002420392

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+41612710555info@5-diagnostics.com

Regulatory Flags#

DUNS number
487256547
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
050700024203855-PLASMA Bivalirudin Control5D-449055D-449052026-04-02
050700024203785-PLASMA Bivalirudin AMR Verification Kit5D-459055D-459052026-04-20

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