ADVIA Centaur NT-PBNPII (PBNPII) 11204753

GUDID 00630414626963

PBNPII - ADVIA Centaur - MCM Set

Siemens Healthcare Diagnostics Inc.

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
Primary Device ID00630414626963
NIH Device Record Key9ac6d2a4-beaa-4b32-9d63-3211c1bc8785
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVIA Centaur NT-PBNPII (PBNPII)
Version Model Number11204753
Catalog Number11204753
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerated
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414626963 [Primary]

FDA Product Code

JJXSingle (specified) analyte controls (assayed and unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-13
Device Publish Date2024-02-05

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

00630414313450 - Atellica CH Billirubin Calibrator (BILI CAL)2024-04-11 Atellica CH Bilirubin Calibrator (BILI CAL)
00630414317427 - Clinistix UTI Test Strips2024-02-29 Test strips for urinary tract infection
00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII)2024-02-13PBNPII - ADVIA Centaur - MCM Set
00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII)2024-02-13 PBNPII - ADVIA Centaur - MCM Set
00630414626970 - ATELLICA IM NT-PBNPII (PBNPII)2024-02-13 PBNPII - ATELLICA IM - MCM Set
00630414284927 - ADVIA Centaur PBNPII2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T
00630414284934 - ADVIA Centaur PBNPII2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T
00630414284941 - Atellica IM PBNPII2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T
00630414284958 - Atellica IM PBNPII2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.