FDA.report

ADVIA Centaur EPO Quality Control

Primary DI
00630414010403
Brand
ADVIA Centaur EPO Quality Control
Company
Siemens Healthcare Diagnostics Inc.
Model
10995099
Catalog number
10995099
Device description
Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL
Published
2019-11-18
Public version status
New
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

Contact Domains

Product Codes

CodeName
JJXSingle (specified) analyte controls (assayed and unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414010403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414010403006304140104036304140104030630414010403

GMDN Terms

TermDefinition
Erythropoietin (EPO) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of erythropoietin (EPO) 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
true
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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