FDA.reportPublic FDA data

Atellica HEMA Cleaner

Primary DI
00630414312460
Brand
Atellica HEMA Cleaner
Company
Siemens Healthcare Diagnostics Inc.
Model
11374306
Catalog number
11374306
Device description
AT HEMA Cleaner
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00630414289984PrimaryGS10
00630414312460Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414289984006304142899846304142899840630414289984
00630414312460006304143124606304143124600630414312460

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13607450016106STA® - WashDIAGNOSTICA STAGOPPM2026-10-15
05407013460206mRNA Buffer 103 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460213mRNA Buffer 103 : 200L BagLonza VerviersPPM2026-09-24
05407013460237mRNA Buffer 112 : 200L BagLonza VerviersPPM2026-09-24
05407013460244mRNA Buffer 112 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460251mRNA Buffer 113 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460268mRNA Buffer 113 : 200L BagLonza VerviersPPM2026-09-24
05407013460282Bulk Packaged ster. filtered WFI - 1LLonza VerviersPPM2026-09-24
04015630967162ISH Peroxidase InhibitorVentana Medical Systems, Inc.PPM2026-07-13
04049016151272FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151289Biotin-labelled anti-human IgGEUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08