FDA.reportPublic FDA data

N Predilution Wells

Primary DI
00842768012174
Brand
N Predilution Wells
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10446521
Catalog number
OVIC11
Device description
The N Predilution Well is used for settings of dilutions of standards, controls and sera.
Published
2017-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DEWIGG, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEWIgg, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943997000BEHRING NEPHELOMETER IIBehring Diagnostics, Inc.1994-10-03DEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768012174PrimaryGS10
00842768024764Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768012174008427680121748427680121740842768012174
00842768024764008427680247648427680247640842768024764

GMDN Terms#

Term, Definition table
TermDefinition
Nephelometry immunoassay analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen using an immunological method which utilizes a nephelometric detection system to determine the rate and/or quantity of particle agglutination occurring through the formation of immune complexes, together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

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
1100
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
00380740169893AlinityABBOTT IRELANDDEW2021-04-29
00380740169909ARCHITECTABBOTT IRELANDDEW2021-04-02
00380740175184ARCHITECTAbbott GmbHDEW2020-11-06
00630414002903BN II SystemSiemens Healthcare Diagnostics Products GmbHDEW2020-09-24
03610230007358Yumizen C1200 Immunoglobulin GHORIBA ABX SASDEW2020-07-13
07613336121320Tina-quant IgG Gen.2Roche Diagnostics GmbHDEW2020-03-05
00380740153922AlinityAbbott GmbHDEW2019-12-24
03573026619527VIDAS® PC SOFTWARE V4.9BIOMERIEUX SADEW2019-12-20
05055273203967IgGRANDOX LABORATORIES LIMITEDDEW2019-06-03
00842768012167N Cuvette Segments for BN IISiemens Healthcare Diagnostics Products GmbHDEW2017-11-15
B1761010Antiserum to Human IgG (gamma chain specific)KENT LABORATORIES INCDEW2016-09-24
05051700010368Human IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID KitTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010399Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk KitTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010443Human IgG - ‘NL’ BINDARID™ Radial Immunodiffusion Kit THE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010917Human IgG1 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010924Human IgG2 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010931Human IgG3 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010948Human IgG3 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05055273203936IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
05055273203950IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
05055273203974IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
00840733101304MERIFLUOR GullSORB MERIDIAN BIOSCIENCE, INC.DEW2016-09-23
04015630913923IGG Immunoglobulin G Turbidimetric)Roche Diagnostics GmbHDEW2016-09-20
04015630919697Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
04015630919710Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
04015630925735Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
05700572000273Poly Rb a Hu Alpha-1-AntitrypsinAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
05700572000860Poly Rb A-Hu IgA, IgG, IgMAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
05700572001386Poly Rb A-Hu IgGAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
00816426020108K-ASSAY® IgG ReagentKAMIYA BIOMEDICAL COMPANY, LLCDEW2016-09-16