FDA.reportPublic FDA data

Fast 96-Well Spectral Calibration Plate with TAMRA™ Dye

Primary DI
10190302000420
Brand
Fast 96-Well Spectral Calibration Plate with TAMRA™ Dye
Company
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Model
4432632
Device description
FAST 96W CALIBRATION TAMRA IVD
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OOIreal time Nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123955000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123955000QUANTSTUDIO DX REAL-TIME PCR INSTRUMENTLife Technologies Corporation2013-03-08OOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302000420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200042010190302000420

GMDN Terms#

Term, Definition table
TermDefinition
PCR instrument calibrator kit IVDA collection of reagents and other associated materials intended to be used to calibrate or verify the performance of a polymerase chain reaction (PCR) analyser to ensure its proper function prior to analysis/processing of clinical samples.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
628548377
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

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