Xprecia™ System PT Controls

Primary DI
00630414170794
Brand
Xprecia™ System PT Controls
Company
Siemens Healthcare Diagnostics Inc.
Model
10873633
Catalog number
10873633
Device description
The Xprecia™ System PT Controls; For use with Xprecia System, supplying assayed controls for prothrombin time (PT).
Published
2016-12-16
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
GGNPLASMA, COAGULATION CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151964000Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics2016-09-30GJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414170794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414170794006304141707946304141707940630414170794

GMDN Terms#

Term, Definition table
TermDefinition
Prothrombin time (PT) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 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
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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