FDA.reportPublic FDA data

Cleaner SCS

Primary DI
00842768008153
Brand
Cleaner SCS
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10446136
Catalog number
OQUB21
Device description
Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems
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
00842768008153PrimaryGS10
00842768018930Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768008153008427680081538427680081530842768008153
00842768018930008427680189308427680189300842768018930

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
6
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
06936895301660BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZW2023-07-05
00842768007781BN II AdditiveSiemens 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