FDA.reportPublic FDA data

Atellica IM SHBG

Primary DI
00630414293868
Brand
Atellica IM SHBG
Company
Siemens Healthcare Diagnostics Inc.
Model
11206312
Catalog number
11206312
Device description
Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 250T
Published
2020-12-12
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
CDZRADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDZRadioimmunoassay, Testosterones And DihydrotestosteroneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151986000
K191533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151986000ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve MaterialSiemens Healthcare Diagnostics, Inc.2016-06-29CDZ
K191533000ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.2019-08-28CDZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293868PrimaryGS10
00630414294285Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293868006304142938686304142938680630414293868
00630414294285006304142942856304142942850630414294285

GMDN Terms#

Term, Definition table
TermDefinition
Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of sex hormone binding globulin (SHBG) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
Lot or batch
true
Expiration date on label
true

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