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Dade Hepzyme

Primary DI
00630414640396
Brand
Dade Hepzyme
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873841
Catalog number
10873841
Device description
Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JBRTEST, HEPARIN NEUTRALIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBRTest, Heparin NeutralizationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925452000DADE HEPZYMEBaxter Diagnostics, Inc.1993-01-11JBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414640396PrimaryGS10
00842768019487Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414640396006304146403966304146403960630414640396
00842768019487008427680194878427680194870842768019487

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation inhibitory substance neutralization IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the neutralization of any coagulation inhibitory substances in a clinical specimen through the addition of phospholipids. This is performed prior to testing using an activated partial thromboplastin time (APTT) test.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842768019487Dade HepzymeSiemens Healthcare Diagnostics Products GmbHJBR2024-03-25
00842768004049Dade® Hepzyme®Siemens Healthcare Diagnostics Products GmbHJBR2016-09-24