FDA.reportPublic FDA data

Berichrom® Heparin UF Control 1

Primary DI
00842768006821
Brand
Berichrom® Heparin UF Control 1
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445985
Catalog number
OPBY03
Device description
For use as a low level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIZPLASMA, CONTROL, NORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIZPlasma, Control, NormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083175000BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2Siemens Healthcare Diagnostics2009-01-26JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768006821PrimaryGS10
00842768019234Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006821008427680068218427680068210842768006821
00842768019234008427680192348427680192340842768019234

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

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
6
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GIZ2016-11-15
00842768006876Berichrom® Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00843876000053CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00843876000060CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00850201006147LAtrol NORMAL CONTROL PLASMABiomedica ADI Inc.GIZ2016-09-20
00845275000559Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIZ2016-09-16
13607450006756STA® - UnicalibratorDIAGNOSTICA STAGOGIZ2016-09-15
15391521420777TriniCHECK™ D-Dimer 1TCOAG IRELAND LIMITEDGIZ2016-09-12
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)HELENA LABORATORIES CORPORATIONGIZ2016-09-07
00855360006243REAADS Coagulation Control 1CORGENIX MEDICAL CORPORATIONGIZ2016-07-14