Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge

Primary DI
00842768016936
Brand
Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
10444901
Catalog number
10444901
Device description
PBNP Flex® reagent cartridge, 120 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
NBCTEST,NATRIURETIC PEPTIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBCTest, Natriuretic PeptideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071767000DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423ADade Behring, Inc.2007-08-04NBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768016936PrimaryGS10
00630414003900Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768016936008427680169368427680169360842768016936
00630414003900006304140039006304140039000630414003900

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide 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 B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) 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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