FDA.reportPublic FDA data

CHORUS NEGATIVE CONTROL/SAMPLE DILUENT

Primary DI
08033891322595
Brand
CHORUS NEGATIVE CONTROL/SAMPLE DILUENT
Company
DIESSE DIAGNOSTICA SENESE SPA
Model
83607
Catalog number
83607
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033891322595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033891322595080338913225958033891322595

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435036669
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033891322571CHORUS CLEANING SOLUTION 200083609836092026-03-23
08033891322588ENZY-WELL/CHORUS WASHING BUFFER83606836062026-03-23
08033891322816CHORUS EVO DECONTAMINATION BUFFER82050820502026-03-23
08033891322823CHORUS EVO SANITIZING SOLUTION82052820522026-03-23
08033891323103CHORUS WASHING BUFFER AUTOIMMUNITY86004860042026-03-23
08033891328849CHORUS SANITIZING SOLUTION83604836042026-03-23
08033891322748CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH82306823062025-08-19
08033891322779CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS82308823082025-08-19
08033891322670CHORUS EVO82000820002025-07-01
08033891322786CHORUS FECAL ELASTASE86114861142025-07-01
08033891328474CHORUS CLIA FECAL ELASTASE82304823042025-07-01
08033891328481CHORUS ELASTASE COPROCOLLECT86116861162025-07-01
08033891320010CHORUS ECHINOCOCCUS IgG81284812842024-01-22
08033891320522VACU-TEC10200102002024-01-22
08033891320645VACU-TEC CUVETTE-L10208102082024-01-22
08033891320690VES-TEC CUVETTE-L10214102142024-01-22
08033891321086VACU-TEC S.C.10600106002024-01-22
08033891321093VACU-TEC S.C. STERILE10602106022024-01-22
08033891322083CHORUS Q FEVER PHASE II IgG81171811712024-01-22
08033891322434CHORUS MEASLES IgG81072810722024-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
05407010128222Bulk Packaged ster. filtered WFI - 500mlLonza VerviersPPM2026-03-30
054070101286350.1 M NaCl Module L : 1L Bag SAMPLELonza VerviersPPM2026-03-30
05407010129861T-32 1000L bagLonza VerviersPPM2026-03-26
05407010129878T-32 200L bagLonza VerviersPPM2026-03-26
05407010129885NaAc-35 - 1000L bagLonza VerviersPPM2026-03-26
05407010129892NaAc-35 - 200L BagLonza VerviersPPM2026-03-26
05407010129908NaAc-35 -1L Sample bagLonza VerviersPPM2026-03-26
05407010129915NaP-55 - 1000LLonza VerviersPPM2026-03-26
05407010129922NaP-55 - 1L sample bagLonza VerviersPPM2026-03-26
05407010129939NaAc-36 -1000L BagLonza VerviersPPM2026-03-26
05407010129946NaAc-36 -1L Sample BagLonza VerviersPPM2026-03-26
05407010129953NaAc-36 -500L BagLonza VerviersPPM2026-03-26
00630414289984Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414290034Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
04049016152019EUROSORB (IFA)EUROIMMUN Medizinische Labordiagnostika AGPPM2025-11-21
05407010129243KH-020 BF-1 1L Sample BagLonza VerviersPPM2025-10-30
05407010129250KH-020 BF-1 1000L BagLonza VerviersPPM2025-10-30
05407010129267KH-020 BF-1 500L BagLonza VerviersPPM2025-10-30
05407010129274NTT-001-L Buffer - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129281NTT-001-L Buffer - 200L bagLonza VerviersPPM2025-10-30
05407010129298NTT-001-L Buffer - 500L bagLonza VerviersPPM2025-10-30
05407010129304NTT-001-K : 1M NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129311NTT-001-K : 1M NaCl - 200L bagLonza VerviersPPM2025-10-30
05407010129328NTT-001-K : 1M NaCl - 500L bagLonza VerviersPPM2025-10-30
05407010129335NTT-001-R : 150 mM NaCl - 1000L bagLonza VerviersPPM2025-10-30
05407010129342NTT-001-R : 150 mM NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30