FDA.reportPublic FDA data

Atellica IM VitD

Primary DI
00630414234472
Brand
Atellica IM VitD
Company
Siemens Healthcare Diagnostics Inc.
Model
11201772
Catalog number
11201772
Device description
Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T
Published
2018-09-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JISCalibrator, primary
MRGSYSTEM, TEST, VITAMIN D

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2
MRGSystem, Test, Vitamin DClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133156000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133156000ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIASiemens Healthcare Diagnostics, Inc.2014-07-24MRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414234472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414234472006304142344726304142344720630414234472

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light
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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