96-Well 0.2-mL Calibration Plate 1 (FAM, VIC, ROX, and SYBR dyes)

GUDID 10190302001304

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument calibration/verification solution IVD Optical instrument performance standard calibrator/control IVD, single-use
Primary Device ID10190302001304
NIH Device Record Key3c07d25c-d1ee-4e2e-91fa-435a88a0584e
Commercial Distribution StatusIn Commercial Distribution
Brand Name96-Well 0.2-mL Calibration Plate 1 (FAM, VIC, ROX, and SYBR dyes)
Version Model NumberA31907
Company DUNS628548377
Company NameLIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110190302001304 [Primary]

FDA Product Code

OOIreal time Nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-12
Device Publish Date2021-02-04

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