FDA.reportPublic FDA data

Atellica CH SPCL CHEM Calibrator

Primary DI
00630414597591
Brand
Atellica CH SPCL CHEM Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
11099438
Catalog number
11099438
Device description
Special Chemistry (SPCL) Calibrator Atellica CH - CAL 10 x 5.0mL
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCalibrator, multi-analyte mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414597591PrimaryGS10
00630414007151Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414597591006304145975916304145975910630414597591
00630414007151006304140071516304140071510630414007151

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.

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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414289953Atellica HEMA Diluent11374303113743032026-02-06
00630414289960Atellica HEMA Diluent11374304113743042026-02-06
00630414312460Atellica HEMA Cleaner11374306113743062026-02-06
00630414312477Atellica HEMA HGB11374307113743072026-02-06
00630414290003Atellica HEMA Baso11374308113743082026-02-06
00630414312484Atellica HEMA RET/PLTO11374309113743092026-02-06
00630414312491Atellica HEMA Diff11374310113743102026-02-06
00630414312507Atellica HEMA Decon11374311113743112026-02-06
00630414323640Atellica HEMA Control (L)11374313113743132026-02-06
00630414323657Atellica HEMA Control (N)11374314113743142026-02-06
00630414323534Atellica HEMA Control (H)11374315113743152026-02-06
00630414323541Atellica HEMA Retic Control (L)11374316113743162026-02-06
00630414323558Atellica HEMA Retic Control (N)11374317113743172026-02-06
00630414323565Atellica HEMA Retic Control (H)11374318113743182026-02-06
00630414323572Atellica HEMA Control BF (N)11374319113743192026-02-06
00630414323589Atellica HEMA Control BF (H)11374320113743202026-02-06
00630414323596Atellica HEMA SMS W-G Stain11559862115598622026-02-06

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