ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low Control

Primary DI
00630414473406
Brand
ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low Control
Company
Siemens Healthcare Diagnostics Inc.
Model
10330063
Catalog number
T03-4417-54
Device description
ADVIA®120/2120/2120i 3 in 1 TESTpoint™ Low Control
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
JCNCONTROL, CELL COUNTER, NORMAL AND ABNORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCNControl, Cell Counter, Normal And AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993825000PARA TECH PLUS RETICSStreck Laboratories, Inc.1999-11-30JCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414473406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414473406006304144734066304144734060630414473406

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of 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, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

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
00630414482446ADVIA® Chemistry LIP Lipase Reagents10311896103118962020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase Reagents10315176103151762020-09-24
00630414526829ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent10335892103358922020-09-24
00630414553191ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated10283347102833472020-09-24
00842768013713Dimension® CTNI Calibrator10444986104449862016-09-24
00842768016936Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge10444901104449012016-09-24
00630414482385ADVIA® Chemistry RF Rheumatoid Factor Reagents10311894103118942016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)10316612103166122016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
00630414947426ADVIA® Chemistry Albumin BCP Calibrator10711842107118422016-09-24
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815762020490Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JCN2025-12-01
30844509000199Para 12® PlusSTRECK, INC.JCN2020-08-24
B787OCK10OLO Control KitS.D. SIGHT DIAGNOSTICS LTDJCN2020-05-04
00815762021978R & D Systems, Inc. CBC-PIX Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JCN2018-12-05
00630414224367ADVIA® 120/2120/2120i TESTpoint Low ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414224381ADVIA® 120/2120/2120i TESTpoint Normal ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414224404ADVIA® 120/2120/2120i TESTpoint High ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473390ADVIA® 120/2120/2120i 3-in-1 TESTpoint Normal ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473413ADVIA® 120/2120/2120i 3-in-1 TESTpoint High ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
20844509001144STaK-ChexSTRECK, INC.JCN2016-09-19
20844509001151STaK-ChexSTRECK, INC.JCN2016-09-19
20844509001168STaK-ChexSTRECK, INC.JCN2016-09-19
30844509001158STaK-ChexSTRECK, INC.JCN2016-09-19
00844509001171STaK-ChexSTRECK, INC.JCN2016-09-19
00844509001188STaK-ChexSTRECK, INC.JCN2016-09-19
20844509000185Para 12 PlusSTRECK, INC.JCN2016-09-14
20844509000192Para 12 PlusSTRECK, INC.JCN2016-09-14
20844509000208Para 12 PlusSTRECK, INC.JCN2016-09-14
00844509000211Para 12 PlusSTRECK, INC.JCN2016-09-14
00844509000228Para 12 PlusSTRECK, INC.JCN2016-09-14
00844509000235Para 12 PlusSTRECK, INC.JCN2016-09-14
00847661002963LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002970LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002987LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002994LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661003007LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00380740017101CELL-DYNABBOTT LABORATORIESJCN2016-06-06
00380740017118CELL-DYNABBOTT LABORATORIESJCN2016-06-06