FDA.reportPublic FDA data

Calcium Gen.2

Primary DI
07613336121092
Brand
Calcium Gen.2
Company
Roche Diagnostics GmbH
Model
08057427190
Catalog number
08057427190
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CHWTitrimetric with EDTA and indicator, calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHWTitrimetric With Edta And Indicator, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113521000CALCIUM GEN. 2Roche Diagnostics2012-05-08CHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121092076133361210927613336121092

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of calcium (Ca2+) in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
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07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
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04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630923991Calcium Gen2Roche Diagnostics GmbHCHW2016-09-20
04015630924004Calcium Gen2Roche Diagnostics GmbHCHW2016-09-20
04015630924035Calcium Gen2Roche Diagnostics GmbHCHW2016-09-20
04015630924042Calcium Gen2Roche Diagnostics GmbHCHW2016-09-20
04015630924936Calcium Gen2Roche Diagnostics GmbHCHW2016-09-20