FDA.reportPublic FDA data

Preciset Lp(a) Gen.2

Primary DI
04015630933914
Brand
Preciset Lp(a) Gen.2
Company
Roche Diagnostics GmbH
Model
5852641160
Catalog number
5852641160
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JITCalibrator, secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630933914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630933914040156309339144015630933914

GMDN Terms#

Term, Definition table
TermDefinition
Lipoprotein A IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
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07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23
07613336218402Elecsys LH09755721190097557211902026-02-19
07613336236499Elecsys BRAHMS PCT10456299190104562991902026-02-19
04015630911707Elecsys Myoglobin STAT CalSet11820893122118208931222016-09-20
04015630918805Cfas PUC3121305122031213051222016-09-20
04015630919932C.f.a.s. PAC3555941190035559411902016-09-20
04015630936373Cfas Proteins11355279160113552791602016-09-20
04015630939060Elecsys Myoglobin Immunoassay12178214160121782141602016-09-20
04015630939114Elecsys BRAHMS PCT505688820050568882002016-09-20
04015630940073Elecsys BRAHMS PCT07301715190073017151902017-04-21
07613336224281PreciControl Rubella IgG09966625190099666251902026-01-28
07613336206737VENTANA DP 600 slide scanner09311360001093113600012025-12-15
07613336232125Ionify Steroids 109629645160096296451602025-12-11
07613336232132Ionify Steroids 209634444160096344441602025-12-11
07613336216958CalSet Phospho-Tau (181P) Plasma09697896190096978961902025-11-18
07613336216965PreciControl Phospho-Tau (181P) Plasma09697926190096979261902025-11-18

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Primary DI, Brand, Company table
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