Abbott mSample Preparation System DBS Buffer Kit 08N80-001

GUDID 00849811004483

Abbott mSample Preparation System DBS Buffer

PROMEGA CORPORATION

Nucleic acid extraction/isolation kit IVD
Primary Device ID00849811004483
NIH Device Record Keyf1d2d034-0548-4593-8dc6-8da258479c2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbbott mSample Preparation System DBS Buffer Kit
Version Model Number08N80-001
Catalog Number08N80-001
Company DUNS089855696
Company NamePROMEGA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100849811004483 [Primary]

FDA Product Code

PPMGeneral Purpose Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-25

Devices Manufactured by PROMEGA CORPORATION

00849811075902 - QuantiFluor® Dx dsDNA System2023-08-23 The QuantiFluor® Dx dsDNA System is a fluorescent dye-based test intended to quantify double-stranded DNA (dsDNA) in a sample c
00849811066115 - Maxwell® CSC Genomic DNA Kit2023-06-20 The Maxwell® CSC Genomic DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isola
00849811069062 - Maxwell® CSC Pathogen Total Nucleic Acid Kit 2023-06-20 The Maxwell® CSC Pathogen Total Nucleic Acid DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to per
00849811051340 - Maxwell® CSC Instrument2022-02-09 The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perf
00849811051739 - Maxwell® CSC RNA Blood Kit2022-02-09 The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolati
00849811051746 - Maxwell® CSC RNA FFPE Kit2022-02-09 The Maxwell® CSC RNA FFPE kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolatio
00849811051753 - Maxwell® CSC DNA FFPE Kit2022-02-09 The Maxwell® CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolatio
00849811051777 - Maxwell® CSC Blood DNA Kit2022-02-09 The Maxwell® CSC Blood DNA kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolati

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.