FDA.reportPublic FDA data

CLINITEK Status® Connector

Primary DI
00630414571263
Brand
CLINITEK Status® Connector
Company
Siemens Healthcare Diagnostics Inc.
Model
10376322
Catalog number
10376322
Device description
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity andcentralized control of all the satellite Point of Care (POC) Clinitek Status+ analyzers. The connector communicates with remote hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
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
CDMDIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
CENDYE-INDICATOR, PH (URINARY, NON-QUANT.)
JFYENZYMATIC METHOD, CREATININE
JHIVisual, pregnancy hCG, prescription use
JILMETHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JINNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JIPBLOOD, OCCULT, ENZYMATIC METHOD, IN URINE
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JJBAZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JREREFRACTOMETER FOR CLINICAL USE
KQOAUTOMATED URINALYSIS SYSTEM
LJXTEST, URINE LEUKOCYTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
JFYEnzymatic Method, CreatinineClinical Chemistry2
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
JIPBlood, Occult, Enzymatic Method, In UrineHematology2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
JRERefractometer For Clinical UseClinical Chemistry1
KQOAutomated Urinalysis SystemClinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091216000CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797Siemens Healthcare Diagnostics2009-10-09JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414571263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414571263006304145712636304145712630630414571263

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel clinical chemistry 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 multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using more two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Max 95% RH at 45'c
Storage Environment Temperature5 Degrees Celsius40 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
Serial number
true

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