FDA.reportPublic FDA data

Acute Care™ D-DIMER CalPak

Primary DI
00842768004575
Brand
Acute Care™ D-DIMER CalPak
Company
Siemens Healthcare Diagnostics Inc.
Model
10445076
Catalog number
CDDMR-C
Device description
The Stratus® CS Acute Care™ DDMR Calibrator (DDMR CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ DDMR method
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063356000STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAKDade Behring, Inc.2007-03-23DAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768004575PrimaryGS10
00630414009896Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768004575008427680045758427680045750842768004575
00630414009896006304140098966304140098960630414009896

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using a fluorescent immunoassay method.

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)405-6473XX@XX.XX
+1(800)405-6473CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
5
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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