FDA.reportPublic FDA data

AI ver2 Tinaquant Apolipoprotein AI ver2

Primary DI
04015630917747
Brand
AI ver2 Tinaquant Apolipoprotein AI ver2
Company
Roche Diagnostics GmbH
Model
3032612122
Catalog number
3032612122
Published
2016-09-20
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
DERALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DERAlpha-1-Lipoprotein, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013249000TINA-QUANT APOLIPOPROTEIN VER.2Roche Diagnostics Corp.2001-11-16DER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630917747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630917747040156309177474015630917747

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of apolipoprotein A-I (Apo A1) lipid in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740170141ARCHITECTABBOTT IRELANDDER2023-08-10
00380740170134AlinityABBOTT IRELANDDER2021-05-19
00380740175139ARCHITECTAbbott GmbHDER2021-02-18
07613336133521Tina-quant Apolipoprotein A-1 ver.2Roche Diagnostics GmbHDER2020-03-16
00380740153908AlinityAbbott GmbHDER2019-07-03
04015630917723Tinaquant Apolipoprotein A1 ver2Roche Diagnostics GmbHDER2016-09-20
04015630928651Tinaquant Apolipoprotein A1 ver2Roche Diagnostics GmbHDER2016-09-20
04015630930227Tinaquant Apolipoprotein AI ver2Roche Diagnostics GmbHDER2016-09-20
00816426020016K-ASSAY® Apo AI ReagentKAMIYA BIOMEDICAL COMPANY, LLCDER2016-09-16
00816426020030K-ASSAY® Apo B ReagentKAMIYA BIOMEDICAL COMPANY, LLCDER2016-09-16
00816426020177K-ASSAY® Apo B Reagent (L)KAMIYA BIOMEDICAL COMPANY, LLCDER2016-09-16
00817302020878CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020885CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020892CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT BL-633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020908CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT AU-633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020915CAROLINA LIQUID CHEMISTRIES CORP.® APO B REAGENT CC633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00380740019716ARCHITECTABBOTT LABORATORIESDER2016-06-06