FDA.reportPublic FDA data

Tina-quant Apolipoprotein A-1 ver.2

Primary DI
07613336133521
Brand
Tina-quant Apolipoprotein A-1 ver.2
Company
Roche Diagnostics GmbH
Model
08105448190
Catalog number
08105448190
Published
2020-03-16
Public version status
New
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
07613336133521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336133521076133361335217613336133521

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

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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04015630917747AI ver2 Tinaquant Apolipoprotein AI ver2Roche Diagnostics GmbHDER2016-09-20
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