FDA.reportPublic FDA data

ADVIA Centaur® VitD DIL

Primary DI
00630414586212
Brand
ADVIA Centaur® VitD DIL
Company
Siemens Healthcare Diagnostics Inc.
Model
10494100
Catalog number
10494100
Device description
Vitamin D Diluent (2PK) - CENTAUR - CAL - 2x25mL
Published
2016-09-24
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
MRGSYSTEM, TEST, VITAMIN D

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110586000ADVIA CENTAUR VITAMIN D TOTAL ASSAYSiemens Healthcare Diagnostics, Inc.2011-10-14MRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414586212PrimaryGS10
00630414005904Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414586212006304145862126304145862120630414586212
00630414005904006304140059046304140059040630414005904

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store upright
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
2
Lot or batch
true
Expiration date on label
true

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00630414611075Atellica CH Crea311537215115372152026-05-08
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00630414653259Atellica CH Crea311537567115375672026-05-08

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Primary DI, Brand, Company table
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00816870023403Vit D Direct AccuBind ELISA Test System - 96 wellsMONOBIND, INC.MRG2024-09-13
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