FDA.reportPublic FDA data

BN II Additive

Primary DI
00842768007781
Brand
BN II Additive
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10446098
Catalog number
OQKY61
Device description
Washing Solution (concentrate) for cleaning the cuvettes in the BN II System
Published
2020-09-24
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
JZWNEPHELOMETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZWNephelometerImmunology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001647000BN PROSPEC SYSTEMDade Behring, Inc.2000-09-26JZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768007781PrimaryGS10
00842768018992Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768007781008427680077818427680077810842768007781
00842768018992008427680189928427680189920842768018992

GMDN Terms#

Term, Definition table
TermDefinition
Buffered wash solution IVD, automated/semi-automated systemA buffered wash solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.

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
10
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
06936895301660BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZW2023-07-05
00842768008153Cleaner SCSSiemens Healthcare Diagnostics Products GmbHJZW2020-09-24
00630414002736BN ProSpec® SystemSiemens Healthcare Diagnostics Products GmbHJZW2020-09-24
00842768012297N Evaporation Caps for Control Vials (2.5 mL)Siemens Healthcare Diagnostics Products GmbHJZW2017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)Siemens Healthcare Diagnostics Products GmbHJZW2017-10-31
00842768012334N Cuvette Segments for BN ProSpec®Siemens Healthcare Diagnostics Products GmbHJZW2017-10-31