FDA.reportPublic FDA data

Atellica HEMA HGB

Primary DI
00630414312477
Brand
Atellica HEMA HGB
Company
Siemens Healthcare Diagnostics Inc.
Model
11374307
Catalog number
11374307
Device description
AT HEMA HGB
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
GGKPRODUCTS, RED-CELL LYSING PRODUCTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGKProducts, Red-Cell Lysing ProductsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414289991PrimaryGS10
00630414312477Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414289991006304142899916304142899910630414289991
00630414312477006304143124776304143124770630414312477

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
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00664369000899LYSERCELL WDF IISYSMEX CORPORATIONGGK2026-04-24
00630414289991Atellica HEMA HGBSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414290027Atellica HEMA DiffSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414290003Atellica HEMA BasoSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414312491Atellica HEMA DiffSiemens Healthcare Diagnostics Inc.GGK2026-02-06
06903053010641M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06936415908805M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06936415908812M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093116M-5LEO(I) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093123M-5LEO(I) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093130M-5LEO(II) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093147M-5LEO(II) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093154M-53LH LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093161M-53LH LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
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07350040796436Swelab Lumi-L1 LyseBoule Medical ABGGK2024-10-04
07350040796443Swelab Lumi-L2 LyseBoule Medical ABGGK2024-10-04
03610230008157NUCEDIFF (1L)HORIBA ABX SASGGK2024-05-30
07540207107490EasySep™ Red Blood Cell Lysis Buffer, 10X ConcentrateStemcell Technologies Canada IncGGK2024-02-08
15099590744854DxHBeckman Coulter, Inc.GGK2023-12-15
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G507ZAPR01000ZAPR™Incell Corporation, LLCGGK2023-09-06
G507ZAPR04000ZAPR™Incell Corporation, LLCGGK2023-09-06
05999883586167Diatro•Diff-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
05999883586105Diatro•Lyse-DIFFDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
15999883586164Diatro•Diff-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
04987562422975SULFOLYSERSYSMEX CORPORATIONGGK2022-11-30
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