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
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00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
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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
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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
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00847817014871VARIANT II TURBO LinkBIO-RAD LABORATORIES, INC.KRZ2016-09-12
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00812137010360CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00812137010421CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00380740017071CELL-DYNABBOTT LABORATORIESKRZ2016-06-06
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