Atellica IM Calibrator Q

Primary DI
00630414598444
Brand
Atellica IM Calibrator Q
Company
Siemens Healthcare Diagnostics Inc.
Model
10995517
Catalog number
10995517
Device description
Calibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Published
2017-12-27
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
MTFTOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950021002
P950021006
P950021007
P950021011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950021002ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYSiemens Healthcare Diagnostics1995-12-22MTG
P950021006ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYSiemens Healthcare Diagnostics1995-12-22MTG
P950021007ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYSiemens Healthcare Diagnostics1995-12-22MTG
P950021011ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYSiemens Healthcare Diagnostics1995-12-22MTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598444PrimaryGS10
00630414190884Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598444006304145984446304145984440630414598444
00630414190884006304141908846304141908840630414190884

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen.

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

Regulatory Flags#

DUNS number
064608573
Device count
2
Lot or batch
true
Expiration date on label
true

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