FDA.reportPublic FDA data

Dimension Human Chorionic Gonadotropin Flex reagent cartridge

Primary DI
00842768013911
Brand
Dimension Human Chorionic Gonadotropin Flex reagent cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
10444914
Catalog number
RF530
Device description
Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970387000HUMAN CHORIONIC GONADOTROPIN METHODDade Chemistry Systems, Inc.1997-03-10DHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768013911PrimaryGS10
00630414004013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768013911008427680139118427680139110842768013911
00630414004013006304140040136304140040130630414004013

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) 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 total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen using an enzyme immunoassay (EIA) 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)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
4
Lot or batch
true
Expiration date on label
true

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00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
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00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

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