FDA.reportPublic FDA data

Stratus® CS Acute Care™ ßhCG DilPak

Primary DI
00842768004421
Brand
Stratus® CS Acute Care™ ßhCG DilPak
Company
Siemens Healthcare Diagnostics Inc.
Model
10445062
Catalog number
CBHCG-D
Device description
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin Dilution Pak (ßhCG DilPak), in vitro diagnostic product intended to be used in conjunction with the Acute Care™ ßhCG TestPak on the Stratus® CS analyzer for the measurement of samples with elevated ßhCG levels.
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
DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
JITCALIBRATOR, SECONDARY
NBCTEST,NATRIURETIC PEPTIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2
JITCalibrator, SecondaryClinical Chemistry2
NBCTest, Natriuretic PeptideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060548000STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAKDade Behring, Inc.2006-04-06DHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768004421PrimaryGS10
00630414009773Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768004421008427680044218427680044210842768004421
00630414009773006304140097736304140097730630414009773

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, 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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