FDA.reportPublic FDA data

Search

138 matching records for Prime.

NDC#

Prime-Gel

Prime Dental Manufacturing, Inc.

Benzocaine

Prime

Newton Laboratories, Inc.

Ginkgo biloba, Ruta graveolens, Agnus castus, Allium sativum, Ambra grisea, Angelica sinensis radix, Aralia quinquefolia, Arnica montana, Arsenicum album, Avena sativa, Baptisia tinctoria, Baryta carbonica, Bryonia, Cantharis, Lachesis mutus, Lycopodium cla...

Prime of Life

Newton Laboratories, Inc.

Agnus, Allium sativum, Ambra, Angelica sinensis radix, Aralia quinquefolia, Arnica, Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. met., Ginkgo

PRIME

Prime Enterprises

Isopropyl Alcohol

PRIME

Prime Enterprises

Ethyl Alcohol

PRIME

Prime Enterprises

Ethyl Alcohol

Prime

Prime Enterprises

Ethyl Alcohol

Prime

Prime Enterprises

Ethyl Alcohol

Prime

Prime Enterprises

Ethyl Alcohol

Prime

Prime Enterprises

Ethyl Alcohol

PRIME

Prime Industries Usa, Inc

Alcohol

Prime

Prime Industries Usa, Inc

BENZALKONIUM CHLORIDE

PRIMENE

Baxter Healthcare Corporation

Isoleucine, leucine, valine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, histidine, alanine, aspartic acid, cysteine, glutamic acid, glycine, proline, serine, tyrosine, ornitine hydrchloride, taurine

DailyMed#

Cream

OXYGEN DEVELOPMENT, LLC

20230210

Prime-Gel

Prime Dental Manufacturing, Inc.

2025-10-22

GMDN Terms#

Dentine bonding agent/set

4,440 GUDID devices

A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may ...

Non-blood cell primer/calibrator/control material IVD, reagent

23 GUDID devices

A substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen.

Cardiopulmonary bypass system priming set

11 GUDID devices

A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to chann...

Assay development analyte-specific reagent IVD

4,532 GUDID devices

An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological...

Dentine bonding agent/set

708 GUDID devices

A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a...

Dental composite resin kit

201 GUDID devices

A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent,...

Dental prosthesis priming agent

52 GUDID devices

A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to...

Nucleic acid sequencing reagent kit IVD

43 GUDID devices

A collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) ...

Nucleic acid amplification mastermix kit IVD

40 GUDID devices

A collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonuc...

Dental acrylic resin kit

24 GUDID devices

A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes acrylic resin material (without hardening fillers/materials) and additional materials to support restoration (e....

Nucleic acid amplification primer IVD

22 GUDID devices

A defined piece of single-stranded nucleic acid intended to be used to initiate the amplification of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, using a nucleic acid amplification te...

Nucleic acid library construction kit IVD

19 GUDID devices

A collection of reagents and other associated materials intended to be used for the construction of fragmented nucleic acids [deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for use in genomic sequencing assays. It typically consists of buffers, prim...

Root canal obturation kit

10 GUDID devices

A collection of sterile dental devices, synthetic materials, and solutions designed to permanently prime, seal, and fill a tooth undergoing a root canal procedure. This device typically includes materials such as a primer (for bonding to the walls of the ca...

HLA class I & II antigen nucleic acid tissue typing IVD, primer

7 GUDID devices

A defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template, in an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple HLA class I an...

Nucleic acid amplification mastermix reagent IVD

5 GUDID devices

A reagent intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using...

Ankylosing spondylitis IVD, primer

1 GUDID devices

A defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inherited genetic condition ankylo...

Trisomy 21 (Down syndrome) IVD, primer

1 GUDID devices

A defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic disorder Down syndr...