Atellica IM SHBG 11206312

GUDID 00630414294285

Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 250T

Siemens Healthcare Diagnostics Inc.

Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Primary Device ID00630414294285
NIH Device Record Keya8a31d66-453d-429b-947b-f6a0a77b37ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtellica IM SHBG
Version Model Number11206312
Catalog Number11206312
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
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
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
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

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright, Protect from light

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414293868 [Primary]
GS100630414294285 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDZRADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-21
Device Publish Date2020-12-12

On-Brand Devices [Atellica IM SHBG]

00630414293752Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 50T
00630414599854Sex Hormone Binding Globulin (SHBG) Atellica IM - RGT 50T
00630414294285Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 250T

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