ADVIA Centaur® FSH MCM

Primary DI
00630414126210
Brand
ADVIA Centaur® FSH MCM
Company
Siemens Healthcare Diagnostics Inc.
Model
10311617
Catalog number
672418000
Device description
Follicular Stimulating Hormone Master Curve Material Set - CENTAUR - CONS
Published
2020-09-24
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
CGJRADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGJRadioimmunoassay, Follicle-Stimulating HormoneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904649000CIBA CORNING ACS FSH IMMUNOASSAYCiba Corning Diagnostics Corp.1990-11-20CGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414126210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414126210006304141262106304141262100630414126210

GMDN Terms#

Term, Definition table
TermDefinition
Follicle stimulating hormone (FSH) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
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
1
Lot or batch
true
Expiration date on label
true

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