FDA.reportPublic FDA data

GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml

Primary DI
04260341780603
Brand
GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml
Company
G o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.
Model
30.9.0290
Catalog number
30.9.0290
Device description
OSMOREF® Reference Solution is intended for use in evaluating the performance of customer osmometers. It is an independent reference for checking the linearity of the instrument in the osmolality range of normal serum.
Published
2021-05-07
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
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032608000GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB2003-10-21JIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260341780603PrimaryGS10
04260341780764Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260341780603042603417806034260341780603
04260341780764042603417807644260341780764

GMDN Terms#

Term, Definition table
TermDefinition
Osmolality IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+493078095880info@gonotec.com

Regulatory Flags#

DUNS number
319441788
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260341780566GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O - 10 x 1mL30.9.010030.9.01002021-05-07
04260341780573GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mL30.9.050030.9.05002021-05-07
04260341780580GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL30.9.085030.9.08502021-05-07
04260341780597GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mL30.9.200030.9.20002021-05-07
04260341780559GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O - 10 x 1mL30.9.002030.9.00202021-05-07
04260341780726GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O - 10 x 1mL30.9.010030.9.01002021-05-07
04260341780733GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mL30.9.050030.9.05002021-05-07
04260341780740GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL30.9.085030.9.08502021-05-07
04260341780757GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mL30.9.200030.9.20002021-05-07
04260341780764GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml30.9.029030.9.02902021-05-07

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Primary DI, Brand, Company table
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