Dimension Cardiac Troponin-I Flex reagent cartridge

Primary DI
00842768013904
Brand
Dimension Cardiac Troponin-I Flex reagent cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
10444896
Catalog number
10444896
Device description
Cardiac Troponin-I Flex® reagent cartridge, 72 tests
Published
2016-09-24
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
MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010313000DIMENSION CTNI FLEX REAGENT CARTRIDGEDade Behring, Inc.2001-04-20MMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768013904PrimaryGS10
00630414003870Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768013904008427680139048427680139040842768013904
00630414003870006304140038706304140038700630414003870

GMDN Terms#

Term, Definition table
TermDefinition
Troponin I IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
005088112
Device count
4
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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