FDA.reportPublic FDA data

ST art®

Primary DI
03607450582307
Brand
ST art®
Company
DIAGNOSTICA STAGO
Model
58230
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GKPINSTRUMENT, COAGULATION, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKPInstrument, Coagulation, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904297000ST-4 COAGULATION INSTRUMENTAmerican Bioproducts Co.1990-11-13GKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607450582307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607450582307036074505823073607450582307

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, laboratory, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Regulatory Flags#

DUNS number
262277122
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450006756STA® - Unicalibrator006752016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
13607450006749STA® - Fibrinogen 5006742016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195226000528ACL TOP 770INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000535ACL TOP 770 LASINSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000542ACL TOP 770sINSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000559ACL TOP 570INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000566ACL TOP 370INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
04987562516797CA CAL SSYSMEX CORPORATIONGKP2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONGKP2024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660SYSMEX CORPORATIONGKP2024-02-22
10850044118042iHealthIHEALTH LAB INC.GKP2022-09-30
10850044118059iHealthIHEALTH LAB INC.GKP2022-09-30
08426950452867HemosIL Reference EmulsionINSTRUMENTATION LABORATORY COMPANYGKP2020-04-09
08426950928027ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANYGKP2018-05-28
00842768012198Behring Coagulation CupSiemens Healthcare Diagnostics Products GmbHGKP2017-10-31
00842768014444BCS® System Cuvette RotorsSiemens Healthcare Diagnostics Products GmbHGKP2017-10-31
04987562205936CA CAL SSYSMEX CORPORATIONGKP2017-10-06
00842768008023BC Validation KitSiemens Healthcare Diagnostics Products GmbHGKP2016-09-24
00630414945514BCS® XP SystemSiemens Healthcare Diagnostics Products GmbHGKP2016-09-24
08426950003106HemosIL Sample DiluentINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950055990HemosIL Cleaning Solution (Clean A)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950062295HemosIL Factor DiluentINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950075899Cuvettes (2400 cuvettes)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497059ACL AcuStar cuvettes (1400 pcs)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950784074ACL TOP 750INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950784081ACL TOP 350 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950927990ACL TOP 700INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950451600ACL TOP CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950453499ACL TOP 500 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497974ACL TOP 700INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497981ACL TOP 700 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497998ACL TOP 700 LASINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23