FDA.reportPublic FDA data

Tinaquant 1Antitrypsin ver2

Primary DI
04015630928415
Brand
Tinaquant 1Antitrypsin ver2
Company
Roche Diagnostics GmbH
Model
5991978190
Catalog number
5991978190
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
DEMALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEMAlpha-1-Antitrypsin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010978000TINA-QUANT ALPHA-1 ANTITRYPSINRochdiag2001-05-18DEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630928415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630928415040156309284154015630928415

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen, using a nephelometry/turbidimetry method. Alpha-1-antitrypsin deficiency is typically associated with liver cirrhosis and pulmonary emphysema.

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

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700010696Human Alpha 1 Antitrypsin NL BINDARID™ KitTHE BINDING SITE GROUP LIMITEDDEM2023-06-29
07613336130230Tina-quant a1-Antitrypsin ver.2Roche Diagnostics GmbHDEM2020-03-05
00380740156299ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740156374ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740156411ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740153519AlinityABBOTT LABORATORIESDEM2019-01-04
00630414596228Atellica CH AATSiemens Healthcare Diagnostics Inc.DEM2017-12-19
00817302023152CLC720 Chemistry Analyzer w/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONDEM2016-12-19
15099590010607AUBECKMAN COULTER IRELAND INC.DEM2016-09-24
B1761220Antiserum to Alpha 1 AntitrypsinKENT LABORATORIES INCDEM2016-09-24
05051700016421Human alpha 1 antitrypsin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDEM2016-09-24
05051700017763Optilite Alpha-1-antitrypsin KitTHE BINDING SITE GROUP LIMITEDDEM2016-09-24
00842768005992Dimension Vista®a1-Antitrypsin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00842768009921N Antiserum to Human a1-AntitrypsinSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00842768009938N Antiserum to Human a1-AntitrypsinSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00630414517728ADVIA® Chemistry AAT Alpha-1-Antitrypsin ReagentsSiemens Healthcare Diagnostics Inc.DEM2016-09-24
04015630916597Tinaquant 1Antitrypsin ver2Roche Diagnostics GmbHDEM2016-09-20
04015630927562Albumin BCPRoche Diagnostics GmbHDEM2016-09-20
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00816426020009K-ASSAY® Alpha-1 AT ReagentKAMIYA BIOMEDICAL COMPANY, LLCDEM2016-09-16
00380740030131ARCHITECTABBOTT LABORATORIESDEM2016-09-09
00380740044862ARCHITECTABBOTT LABORATORIESDEM2016-09-09
00380740054151ARCHITECTABBOTT LABORATORIESDEM2016-09-09
15099590224042IMMAGEBeckman Coulter, Inc.DEM2016-08-24
10758750002290VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DEM2016-08-23