FDA.reportPublic FDA data

N/T Protein Control PY

Primary DI
00842768021138
Brand
N/T Protein Control PY
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10446656
Catalog number
OWSY15
Device description
Assayed control for Fibrinogen, Antithrombin III, Plasminogen and C1 Inhibitor assays on BN Systems
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
GILPLASMA, FIBRINOGEN CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GILPlasma, Fibrinogen ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962407000N/T PROTEIN CONTROL PYBehring Diagnostics, Inc.1996-07-29GIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768021138PrimaryGS10
00842768018565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768021138008427680211388427680211380842768021138
00842768018565008427680185658427680185650842768018565

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins 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)664-3822XX@XX.XX
+1(800)664-3822CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859110005128Validate Lgc Clinical Diagnostics, Inc.GIL2018-01-18
00859110005135Validate Lgc Clinical Diagnostics, Inc.GIL2018-01-18
00859110005142Validate Lgc Clinical Diagnostics, Inc.GIL2018-01-18
00817089020696DiazymeDIAZYME LABORATORIES, INC.GIL2016-11-03