FDA.reportPublic FDA data

Atellica HEMA SMS M-W Stain

Primary DI
00630414323633
Brand
Atellica HEMA SMS M-W Stain
Company
Siemens Healthcare Diagnostics Inc.
Model
11559864
Catalog number
11559864
Device description
AT HEMA SMS M-W Stain
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
IAFWRIGHT'S STAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IAFWright'S StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414626253PrimaryGS10
00630414323633Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414626253006304146262536304146262530630414626253
00630414323633006304143236336304143236330630414323633

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 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#

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Primary DIBrandModelCatalogPublished
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00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414619262Atellica HEMA SMS M-W BufferSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414626253Atellica HEMA SMS M-W StainSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414323619Atellica HEMA SMS M-W BufferSiemens Healthcare Diagnostics Inc.IAF2026-02-06
14719874743564LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2026-02-06
14719874742796LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2025-02-16
14719874742802LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2025-02-16
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00673693067744EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-09-06
00673693068161EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-09-05
00673693090384EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-09-05
00673693090407EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-09-05
00860011780502Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
00860011780519Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
00860011780526Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
04048474058277Histamine ELISA DRG Instruments Gesellschaft mit beschränkter HaftungIAF2023-09-01
00840239058270Histamine ELISA DRG International IncIAF2023-08-26
07290016650617QwikCheck DFI KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.IAF2023-06-08
14719874741591LensHooke Sperm DNA fragmentation test kit (SCD assay)BONRAYBIO CO., LTD.IAF2021-11-18
00630414473499Hematek® Stain Pak - Modified Wright's StainSiemens Healthcare Diagnostics Inc.IAF2020-09-24
00630414503936ADVIA® Autoslide Modified Wright's StainSiemens Healthcare Diagnostics Inc.IAF2020-09-24
00630414503967ADVIA® Autoslide Modified Wright's BufferSiemens Healthcare Diagnostics Inc.IAF2020-09-24
10885380152283CARDINAL HEALTHCardinal Health 200, LLCIAF2018-01-30