FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge C3

Primary DI
00842768005220
Brand
Dimension® Flex® reagent cartridge C3
Company
Siemens Healthcare Diagnostics Inc.
Model
10444980
Catalog number
DF101
Device description
Complement C3 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
CZWCOMPLEMENT C3, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CZWComplement C3, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994296000DIMENSION C3 FLEX REAGENT CARTRIDGEDade Behring, Inc.2000-03-01CZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005220PrimaryGS10
00630414004563Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005220008427680052208427680052200842768005220
00630414004563006304140045636304140045630630414004563

GMDN Terms#

Term, Definition table
TermDefinition
Complement components C3/C3c IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade components C3 and/or C3c in a clinical specimen, using a nephelometry/turbidimetry 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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00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
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00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740175153ARCHITECTAbbott GmbHCZW2020-11-06
07613336133590Tina-quant Complement C3c Ver.2Roche Diagnostics GmbHCZW2020-03-05
00380740150662AlinityAbbott GmbHCZW2019-06-27
00630414595665Atellica CH C3Siemens Healthcare Diagnostics Inc.CZW2017-12-27
15099590010560AUBeckman Coulter, Inc.CZW2016-09-24
B1761050Antiserum to Human C-3 (b1c/b1a)KENT LABORATORIES INCCZW2016-09-24
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B1761190Antiserum to Human C-3 (b1c)KENT LABORATORIES INCCZW2016-09-24
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05051700010559Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700015578Human C3c Kit for use on the SPAplusTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700017596Optilite C3c KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
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00842768009723N Antiserum to Human C3cSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00630414517735ADVIA® Chemistry C3 Complement C3 ReagentsSiemens Healthcare Diagnostics Inc.CZW2016-09-24
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04015630917709Tinaquant Complement C3c ver2Roche Diagnostics GmbHCZW2016-09-20
04015630928422Tinaquant Complement C3c ver2Roche Diagnostics GmbHCZW2016-09-20
00813545023829Scanlisa C3d Elisa 96 Test SCIMEDX CORPORATIONCZW2016-09-20
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00817302020922CAROLINA LIQUID CHEMISTRIES CORP.® C3 Complement C3 CC634CAROLINA LIQUID CHEMISTRIES CORPORATIONCZW2016-09-01
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