FDA.reportPublic FDA data

ADVIA® 120/2120/2120i SETpoint

Primary DI
00630414224343
Brand
ADVIA® 120/2120/2120i SETpoint
Company
Siemens Healthcare Diagnostics Inc.
Model
10312285
Catalog number
T03-3685-52
Device description
ADVIA®120/2120/2120i SETpoint™
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRZCALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRZCalibrator For Hemoglobin And Hematocrit MeasurementHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K840261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840261000CAL-CHEX, A HEMATOLOGY CALIBRATORStreck Laboratories, Inc.1984-02-21KRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414224343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414224343006304142243436304142243430630414224343

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Protect from freezing
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KRZ2026-02-06
00380740151294AlinityAbbott GmbHKRZ2023-11-16
00630414600826ADVIA® 360/560 CalibratorSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
04015630921096Cfas HbA1cRoche Diagnostics GmbHKRZ2016-09-20
20844509000246Cal-ChexSTRECK, INC.KRZ2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
30844509000243Cal-Chex STRECK, INC.KRZ2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KRZ2016-09-16
00847817000324VARIANT II Hemoglobin A1cBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817011979VARIANT II Hemoglobin A1cBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817013966VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014154VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014406VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014871VARIANT II TURBO LinkBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00380740003609ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00380740003616ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00380740003623ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00812137010223Boule CalCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-06
00812137010360CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00812137010421CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00380740017071CELL-DYNABBOTT LABORATORIESKRZ2016-06-06
00380740020347CELL-DYNABBOTT LABORATORIESKRZ2016-06-06