FDA.reportPublic FDA data

Ser-T-Cal Multicalibrator

Primary DI
00657498001127
Brand
Ser-T-Cal Multicalibrator
Company
STANBIO LABORATORY, L.P.
Model
0550-605
Catalog number
0550-605
Device description
For use as a multi-calibrator serum to calibrate different chemistry reagent used in manual and automated clinical chemistry methods.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498001127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498001127006574980011276574980011270657498001127

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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