FDA.reportPublic FDA data

Dade® Hepzyme®

Primary DI
00842768004049
Brand
Dade® Hepzyme®
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445730
Catalog number
B4240-10
Device description
Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Published
2016-09-24
Public version status
Update
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
00842768004049PrimaryGS10
00842768019487Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768004049008427680040498427680040490842768004049
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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233XX@XX.XX
+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
00630414640396Dade HepzymeSiemens Healthcare Diagnostics Products GmbHJBR2024-03-25
00842768019487Dade HepzymeSiemens Healthcare Diagnostics Products GmbHJBR2024-03-25