ADVIA Centaur Androstenedione kit 10997290

GUDID 00630414603445

Androstenedione (Andro) ADVIA Centaur - RGT 50T

Siemens Healthcare Diagnostics Inc.

Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay Androstenedione IVD, kit, chemiluminescent immunoassay
Primary Device ID00630414603445
NIH Device Record Key3aa4c12a-cf0e-4596-9a19-39dd49d30b15
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVIA Centaur Androstenedione kit
Version Model Number10997290
Catalog Number10997290
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
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do Not Freeze, Resuspend
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414603445 [Primary]

FDA Product Code

CIZRADIOIMMUNOASSAY, ANDROSTENEDIONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-04
Device Publish Date2019-10-25

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

00630414317427 - Clinistix UTI Test Strips2024-02-29 Test strips for urinary tract infection
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
00630414305097 - Atellica CH Anti-Streptolysin-O_3 (ASO_3)2024-02-12 Antistreptolysin O (ASO_3) Atellica CH

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