Stratus® CS

Primary DI
00842768024863
Brand
Stratus® CS
Company
Siemens Healthcare Diagnostics Inc.
Model
10444834
Catalog number
758000.901
Device description
The Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv
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
JHXFLUOROMETRIC METHOD, CPK OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHXFluorometric Method, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984067000STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAKDade Behring, Inc.1999-01-13JHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768024863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768024863008427680248638427680248630842768024863

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratory, semi-automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)405-6473XX@XX.XX
+1(800)405-6473CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

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00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30014613337164TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337928TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337942TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
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00842768004438Stratus® CS STAT Fluorometric Analyzer CannulaSiemens Healthcare Diagnostics Inc.JHX2016-09-24
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00842768004520Stratus® CS Acute Care™ cTNI TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
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