FDA.reportPublic FDA data

Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application

Primary DI
04015630934560
Brand
Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application
Company
Roche Diagnostics GmbH
Model
04528123160
Catalog number
04528123160
Published
2016-09-23
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
PDJHemoglobin A1c Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDJHemoglobin A1c Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN130002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN130002000TINA-QUANT HBA1C GEN. 2 TEST SYSTEMRoche Diagnostics2013-05-23PDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630934560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630934560040156309345604015630934560

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) 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

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Primary DI, Brand, Company table
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