FDA.report

ADVIA Cystatin C_2 Calibrator

Primary DI
00630414224923
Brand
ADVIA Cystatin C_2 Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
10734510
Catalog number
10734510
Device description
ADVIA Chemistry Cystatin C_2 Calibrator
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JITCalibrator, secondary

Product Code Classifications

CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414224923PrimaryGS10

GMDN Terms

TermDefinition
Cystatin C IVD, calibratorA material which is used to establish known points of reference for an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags

DUNS number
064608573
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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