FDA.reportPublic FDA data

Dimension® IBCT Calibrator

Primary DI
00842768005206
Brand
Dimension® IBCT Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
10445006
Catalog number
DC84
Device description
IBCT (Total Iron Binding Protein) Calibrator, 2x3x1mL
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
JISCALIBRATOR, PRIMARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994114000DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATORDade Behring, Inc.2000-01-20JIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005206PrimaryGS10
00630414017099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005206008427680052068427680052060842768005206
00630414017099006304140170996304140170990630414017099

GMDN Terms#

Term, Definition table
TermDefinition
Total iron binding capacity (TIBC) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total iron binding capacity (TIBC) of a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
6
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414653259Atellica CH Crea311537567115375672026-05-08

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