FDA.reportPublic FDA data

Atellica HEMA SMS M-W Buffer

Primary DI
00630414323619
Brand
Atellica HEMA SMS M-W Buffer
Company
Siemens Healthcare Diagnostics Inc.
Model
11559865
Catalog number
11559865
Device description
AT HEMA SMS M-W Buffer
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
00630414619262PrimaryGS10
00630414323619Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414619262006304146192626304146192620630414619262
00630414323619006304143236196304143236190630414323619

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

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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
00630414323633Atellica HEMA SMS M-W StainSiemens Healthcare Diagnostics Inc.IAF2026-02-06
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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