Remel Atlanta A Div Of Remel Inc

FDA Filings

This page includes the latest FDA filings for Remel Atlanta A Div Of Remel Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1031428
FEI Number1031428
NameREMEL ATLANTA, A DIV. OF REMEL, INC.
Owner & OperatorThermo Fisher Scientific
Contact Address168 Third Avenue --
Waltham MA 02451 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2797 Peterson Pl
NORCROSS, GA 30071 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
BactiStaph Latex2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID CB Plus System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID Yeast Plus System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Bacticard Strep2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Bacticard Candida2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Bacticard E.coli2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RIM E.coli O157:H7 Latex2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R30851502 Protease Tablet2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R30851501 Cryptococcus LTX Antigen Test 50TST/KT2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Cryptococcus Latex Antigen Test2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
LAP Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Indoxyl Acetate Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Bacticard Neisseria2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
M. pneumoniae IgG/IgM Antibody2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Niacin Control Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
LAP Disk w/Reagent2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Nitrate Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Vancomycin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Catarrhalis Test Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID NF Plus System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Candida albicans Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
C. Albicans disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID ANA II System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
ALN Disk w/Reagent2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
PRO Disk w/Reagent2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID NH System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
PYR/Esculin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Neisseria Enzyme Test (NET)2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
NET2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
PYR Disk w/Reagent2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
PYR Disk Test2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
MUG Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID SS/u System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID ONE System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Caffeic Acid Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Pyridoxal Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Niacin Reagent Strip2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Microdase Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Colistin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Penicillin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Rifampin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Novobiocin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Haemophilus Identification Kit2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID STR System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Oxy-Swab2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Urea-PDA Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Porphyrin Reagent2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Bile Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Kanamycin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Beta Lysin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Nitrocefin Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
A.L.A. Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Hippurate Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Nitrate Swab2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Beta Lactam Reagent Disk2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Micro-ID Microbial Identification System2012-11-14
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Color Slide II Mononucleosis Test2008-03-11
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Oxoid "IM" Kit2007-11-19
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Mono-Lex System2007-11-19
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
SPS Disk2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID Staph Plus Panels2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID Spot Indole Reagent2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID Nitrate B Reagent2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
RapID Nitrate A Reagent2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21395 Reagent QC Kit KT/30TST2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21281 VP-B (40% KOH) BTL/25ml2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21258 PYR Reagent2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21254 Potassium Tellurite (0.2%)2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21251 Potassium Hydroxide (KOH) 3%2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21245 Spot Indole Reagent (DMACA)2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21244 Nitrate Reagent B for AFB2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21243 Nitrate Reagent A for AFB2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21242 Nitrate Reagent B2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21239 Nitrate Reagent A2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21238 Ninhydrin Reagent2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21233 Potassium Hydroxide (KOH) 20% w/glycerol2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21231 Potassium Hydroxide (KOH) 20%2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21230 Potassium Hydroxide (KOH) 10%2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21227 Indole Reagent,Kovac's2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21226 Gelatin Reagent (12.5%)2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21221 Hippurate Hydrolysis Reagent2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21218 Ferric Chloride-PDA (10%)2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21216 Ferric Ammonium Citrate (20%)2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21215 Esculin Hydrolysis Reagent2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21213 Indole Reagent,Ehrlich's2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21211 Anaer Nitrate Reagent B2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21209 Bile Solubility Reagent (2%)2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21206 Bile Solubility Reagent (10%)2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21201 Anaer Nitrate Reagent A2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R21200 VP-A (alpha napthol 5%)2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R211348 Enterococcus/Grp A Strep Screen2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R211347 E. coli Screen w/Kovacs2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
R01563 MacConkey w/Sorbitol,MUG2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Pathotec CO2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Oxichrome Reagent2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Micro-ID Listeria Identification System2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
M. Cat. Butyrate Disk2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Legionella Kit Buffer2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Gram-Sure Disk2005-05-31
REMEL ATLANTA, A DIV. OF REMEL, INC. [Thermo Fisher Scientific]
Multiple1978-06-21

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