FDA.reportPublic FDA data

Atellica CH CRP_2 Calibrator

Primary DI
00630414597515
Brand
Atellica CH CRP_2 Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
11099430
Catalog number
11099430
Device description
C-Reative Protein (CRP) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL
Published
2017-12-22
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072658000ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORSSiemens Medical Solutions Diagnostics2008-04-01DCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414597515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414597515006304145975156304145975150630414597515

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
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

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