FDA Verification Portal

× UPDATE! Updated as of 11 November 2024.

	Product Information	Registration Number	Generic Name	Brand Name	Dosage Strength	Dosage Form	Classification	Packaging	Pharmacologic Category	Manufacturer	Country of Origin	Trader	Importer	Distributor	Application Type	Issuance Date	Expiry Date
View	-	VR-MD0105	Disposable Syringe (Luer Lock) with Needle (Vet.)	Nobivac	N/A	N/A	N/A	: Each box contains: Disposable Syringe x 2 mL + Needle (23G and 21G) (Box of 100's)	Veterinary Medical Device (VMD) (Syringe)	Sol-Millenium Medical Ltd	U.S.A		MSD Animal Health (Phils.), Inc.	MSD Animal Health (Phils.), Inc.	Initial (Vet.)	08 March 2024	08 March 2029
View	-	VR-MD0106	Aerosol Vaccination Device (Vet.)	E-Trolley Spray Wagon	None	N/A	N/A	Each box contains: Aerosol Vaccination Device. + Spare Parts Accessories	Veterinary Medical Device (VMD) (Vaccinator)	Giordano Poultry Plast S.p.a.	Italy		MSD Animal Health (Phils.), Inc.	MSD Animal Health (Phils.), Inc.	Initial (Vet.)	08 March 2024	08 March 2029
View	-	VR-MD0107	Automatic Vaccination Device (Vet.)	Nobilis Double Breast Vaccinator	None	N/A	N/A	Each box contains: Vaccinator Device + Electricity Plugs x 3's + Vaccine Vial Holder x 1's + Dripping Chambers x 5's Syringe 0.5 mL x 2's + Allen Keys 5 mm x 1's + Fixation Clamp x 1's + Breast Plate Layer Type x 1's Breast Plate Breeder Type x 1's + Reusable Needles x 25's (Box of 12's) + Syringe Spare Part Set x 2's Measurement Tool x 1's + Dosage Measurement Cup x 1's+ Lubricating Oil x 1's	Veterinary Medical Device (VMD) (Vaccinator)	Henke-Sass, Wolf GmbH	Germany		MSD Animal Health (Phils.), Inc.	MSD Animal Health (Phils.), Inc.	Initial (Vet.)	08 March 2024	08 March 2029
View	-	VR-MD0108	Ultra-Low Volume (ULV) Fogging Machine (Vet.)	Vectorfog ULV C150+	None	None	N/A	Each box contains: Fogging Device + Spare Parts	Veterinary Medical Device (VMD)	Vectornate Korea Inc.	Korea		MSD Animal Health (Phils.), Inc.	MSD Animal Health (Phils.), Inc.	Initial (Vet.)	08 March 2024	08 March 2029
View	-	VR-MD0109	Subcutaneous/Intraocular/Oral Vaccination Device (Vet.)	Innoject Pro	None	None	None	Each box contains: Vaccination Machine + Spare Parts	Veterinary Medical Device (VMD) (Vaccinator)	Automazioni VX S.r.1.	Italy		MSD Animal Health (Phils.), Inc.	MSD Animal Health (Phils.), Inc.	Initial (Vet.)	08 March 2024	08 March 2029
View	-	VR-MD0110	Subcutaneous/Intraocular/Oral Vaccination Device (Vet.)	Innoject Pro	None	None	N/A	Each box contains: Vaccination Device + Spare Parts	Veterinary Medical Device (VMD) (Vaccinator)	Automazioni VX S.r.l.	Italy		MSD Animal Health (Phils.), Inc.	MSD Animal Health (Phils.), Inc.	Initial (Vet.)	08 March 2024	08 March 2029
View	-	VR-MD0112	African Swine Fever (ASF) Virus Antibody Test Kit (Vet.)	None	None	None	None	Each box contains: Coated Microplates x 2's+ Positive Control x 1 mL + Negative Control x 1 mL + Dilution Buffer 19 x 60 mL + Conjugate 10x x 6 mL + Dilution Buffer 12 x 60 mL + Wash Solution 20x x 60 mL + Substrate Solution x 60 mL Stop Solution x 60 mL; and Microplates x 5's Positive Control x 1 mL (Box of 2's) Negative Control x 1 mL (Box of 2's) + Dilution Buffer 19 x 60 mL Conjugate 10x x 6 mL Dilution Buffer 12 x 60 mL (Box of 2's)+ Wash Solution 20x x 60 mL Substrate Solution x 60 mL + Stop Solution x 60 mL	Veterinary Diagnostic Kit (IVD) [Enzyme-Linked Immunosorbent Assay]	Innovative Diagnostics SARL	France		Lifeline Diagnostics Supplies, Inc.	Lifeline Diagnostics Supplies, Inc.	Initial (Vet.)	14 March 2024	14 March 2026
View	-	VR-MD0115	Actinobacillus pleuropneumoniae (APP) Polymerase Chain Reaction (PCR) Detection Kit (Vet.)	Kylt APP	None	None	N/A	Each box contains: Reaction Mix in PE vial x 450 μl Positive Control x 2's Negative Control x 1 mL; and Reaction Mix in PE vial x 450 μl (Box of 4's) + Positive Control x 4's + Negative Control x 1 mL	Veterinary Diagnostic Kit (IVD)	San Group Biotech Germany GmbH	Germany		San Group Biotech Philippines, Inc.	San Group Biotech Philippines, Inc.	Initial (Vet.)	20 March 2024	20 March 2029
View	-	VR-MD0116	Foot and Mouth Disease (FMD) Virus Antibody Detection Kit (Vet.)	Priocheck FMDV NS Ab Strip	None	None	None	Each box contains: Test Plate x 5's + Conjugate (30x) x 2.2 mL + Dilution Buffer (2x) x 60 mL + Additive x 2.5 mL (Box of 5's) + Demineralized Water x 10 mL (Box of 2's)+ Washing Fluid (200x) x 60 mL + Positive Control x 3.2 mL + Weak Positive Control x 3.2 mL + Negative Control 3.2 mL + Chromogen (TMB) Substrate x 60 mL + Stop Solution x 60 mL	Veterinary Diagnostic Kit (IVD) [Enzyme-Linked Immunosorbent Assay]	Prionics Lelystad B.V.	Netherlands	Life Technologies Holdings Pte. Ltd.	Infinnomed Enterprise	Infinnomed Enterprise	Initial (Vet.)	10 May 2024	10 May 2029
View	-	VR-MD0117	African Swine Fever (ASF) Virus Polymerase Chain Reaction (PCR) Detection Kit (Vet.)	None	None	None	None	Each box contains: Reaction Solution in PP vial with Colourless Cap x 16's + Positive Control in PP vial with Red Cap x 240 μL + Negative Control in PP vial with White x 240 μL	Veterinary Diagnostic Kit (IVD) (Polymerase Chain Reaction)	Shandong Xinda Gene Technology Co., Ltd	China		Deel Corporation	Deel Corporation	Initial (Vet.)	22 May 2024	22 May 2027
View	-	VR-MD0118	Avian Influenza (AI) Type A Virus Subtypes H5, H7 and H9 Polymerase Chain Reaction (PCR) Detection Kit (Vet.)	Kylt H5/H7/H9	NA	Na	N/A	Each box contains: RT PCR Mix in PP vial x 280 μl Detection Mix in PP vial with Yellow Cap x 1's+ Positive Control in PP vial with Red Cap x 2's+ Negative Control in PP vial with Blue Cap x 1 mL; and RT PCR Mix in PP vial x 280 μl (Box of 4's)+ Detection Mix in PP vial with Yellow Cap x 4's+ Positive Control in Red PP vial with Red Cap x 4's + Negative Control in PP vial with Blue Cap x 1 mL	Veterinary Diagnostic Kit (IVD) [Real-Time Polymerase Chain Reaction]	San Group Biotech Germany GmbH	Germany		San Group Biotech Philippines, Inc	San Group Biotech Philippines, Inc	Initial (Vet.)	23 May 2024	23 May 2029
View	-	VR-MD0113	Newcastle Disease (ND) Virus Antibody Test Kit (Vet.)	None	None	None	None	Each box contains: Coated Microplates x 5's+ Positive Control x 3.5 mL + Negative Control x 3.5 mL + Dilution Buffer 14 x 60 mL (Box of 3's) Conjugate 10x x 7 mL + Dilution Buffer 3 x 60 mL + Wash Solution 20x x 60 mL + Substrate Solution x 60 mL + Stop Solution x 60 mL; and Coated Microplates x 10's+ Positive Control x 3.5 mL (Box of 2's) + Negative Control x 3.5 mL (Box of 2's) + Dilution Buffer 14 x 60 mL (Box of 6's)+ Conjugate 10x x 7 mL (Box of 2's) + Dilution Buffer 3 x 60 mL (Box of 2's) + Wash Solution 20x x 60 mL (Box of 2's) + Substrate Solution x 60 mL (Box of 2's) + Stop Solution x 60 mL (Box of 2's)	Veterinary Diagnostic Kit (IVD) [Enzyme-Linked Immunosorbent Assay]	Innovative Diagnostics SARL	France		Lifeline Diagnostics Supplies, Inc.	Lifeline Diagnostics Supplies, Inc.	Initial (Vet.)	15 March 2024	15 March 2026
View	-	VR-MD0114	Aujeszky Disease Virus Antibody Test Kit (Vet.)	None	None	None	None	Each box contains: Coated Microplates x 5's+ Positive Control x 1 mL (Box of 2's) Negative Control x 1 mL (Box of 2's) + Dilution Buffer 13 x 60 mL + Conjugate 10x x 6 mL + Dilution Buffer 12 x 60 mL + Wash Solution 20x x 60 mL + Substrate Solution x 60 mL + Stop Solution x 60 mL; and Coated Microplates x 10's + Positive Control x 1 mL (Box of 3's) + Negative Control x 31 mL (Box of 3's) + Dilution Buffer 13 x 60 mL (Box of 2's) + Conjugate 10x x 6 mL (Box of 2's)+ Dilution Buffer 12 x 60 mL (Box of 2's) Wash Solution 20x x 60 mL (Box of 2's) + Substrate Solution x 60 mL (Box of 2's)+ Stop Solution x 60 mL (Box of 2's)	Veterinary Diagnostic Kit (IVD) [Enzyme-Linked Immunosorbent Assay]	Innovative Diagnostics SARL	France		Lifeline Diagnostics Supplies, Inc.	Lifeline Diagnostics Supplies, Inc.	Initial (Vet.)	15 March 2024	15 March 2026
View	-	VR-MD0119	African Swine Fever (ASF) Virus Polymerase Chain Reaction. (PCR) Detection Kit (Vet.)	Kylt ASF	NA	Na	Na	Each box contains: Reaction Mix in PP vial with Green Cap x 450 μL Positive Control in PP vial with Red Cap x 50 μL (Box of 2's) + Negative Control in PP vial with Blue Cap x 1 mL; Reaction Mix in PP vial with Green Cap x 450 μL (Box of 4's) Positive Control in PP vial with Red Cap x 50 μL (Box of 4's) Negative Control in PP vial with Blue Cap x 1 mL; and Reaction Mix PP vial with Green Cap x 450 μL (Box of 16's) Positive Control in PP vial with Red Cap x 50 μL + Negative Control in PP vial with Blue Cap x 1 mL	Veterinary Diagnostic Kit (IVD) [Real-Time Polymerase Chain Reaction]	San Group Biotech Germany GmbH	Germany		San Group Biotech Philippines, Inc	San Group Biotech Philippines, Inc	Initial (Vet.)	24 May 2024	24 May 2029
View	-	VR-MD0120	African Swine Fever (ASF) Virus Polymerase Chain Reaction (PCR) Detection Kit (Vet.)	Vetmax African Swine Fever Virus Detection Kit	N/A	N/A	N/A	Master-Mix in PP vial with Green Cap x 1 mL (Box of 2's) External Positive Control in PP vial with Brown. Cap x 90 μL (Box of 2's) + Internal Positive Control in PP vial with Yellow Cap x 500 μL	In-Vitro Medical Device Veterinary (IVD) [Real-Time Polymerase Chain Reaction]	Thermo Fisher Scientific-Laboratories Service International	France		Infinnomed Enterprise	Infinnomed Enterprise	Initial (Vet.)	31 May 2024	31 May 2029
View	-	VR-MD0122	Canine Parvovirus (CPV) Antigen Detection Kit (Vet.)	Rapigen Canine Parvovirus Ag Test	N/A	N/A	N/A	Each box contains: Test Device in Aluminum Pouch + Assay Diluent Tube x 0.7 mL + Filter Cap + Cotton Swab (Box of 10's)	Veterinary Diagnostic Kit (IVD) (Immunochromatographic Assay)	Rapigen, Inc.	Korea		Broadchem Philippines Biopharma Corporation	Broadchem Philippines Biopharma Corporation	Initial (Vet.)	05 June 2024	05 June 2029
View	-	VR-MD0123	Canine Heartworm (CHW) Antigen Detection Kit (Vet.)	Rapigen Canine Heartworm Ag Test	N/A	N/A	N/A	Each box contains: Test Device in Aluminum Pouch x 10's + Assay Buffer Bottle x 3 mL + Dropper x 10's	Veterinary Diagnostic Kit (IVD) (Immunochromatographic Assay)	Rapigen, Inc.	Korea		Broadchem Philippines Biopharma Corporation	Broadchem Philippines Biopharma Corporation	Initial (Vet.)	05 June 2024	05 June 2029
View	-	VR-MD0124	Porcine Circovirus (PCV) Genotype 2a, 2b and 2d Polymerase Chain Reaction (PCR) Detection Kit (Vet.)	Kylt PCV-2 Typing	None	None	None	Each box contains: Reaction Mix in PP vial with Brown Cap x 450 μL + Positive Control in PP vial with Red Cap x 2's + Negative Control in PP vial with Blue Cap x 1 mL; and Reaction Mix in PP vial with Brown Cap x 450 μL (Box of 4's) Positive Control in PP vial with Red Cap x 4's + Negative Control in PP vial with Blue Cap x 1 mL	Veterinary Diagnostic Kit (IVD) [Real-Time Polymerase Chain Reaction]	San Group Biotech Germany GmbH	Germany		San Group Biotech Philippines, Inc	San Group Biotech Philippines, Inc	Initial (Vet.)	21 June 2024	21 June 2029
View	-	VR-MD0125	Salmonella spp Polymerase Chain Reaction (PCR) Detection Kit (Vet.)	Kylt Salmonella spp 2.0	NA	Na	Na	Each box contains: Reaction Mix in PP vial with Brown Cap x 450 μl (Box of 4's) + Positive Control in PP vial with Red Cap x 2's + Negative Control in PP vial with Red Cap x 1 mL	Veterinary Diagnostic Kit (IVD) [Real-Time Polymerase Chain Reaction]	San Group Biotech Germany GmbH	Germany		San Group Biotech Philippines, Inc	San Group Biotech Philippines, Inc	Initial (Vet.)	21 June 2024	21 June 2029
View	-	VR-MD0126	Mycoplasma_gallisepticum and Mycoplasma synoviae Polymerase Chain Reaction (PCR) Detection Kit (Vet.)	Kylt MGS Triplex	None	None	None	Each box contains: Reaction Mix in PP vial with Brown Cap x 450 μl + Positive Control in PP vial with Red Cap x 2's + Negative Control in PP vial with Blue Cap x 1 mL; and Reaction Mix in PP vial with Brown Cap x 450 μl (Box of 4's) Positive Control in PP vial with Red Cap x 4's + Negative Control in PP vial with Blue Cap x 1 mL	Veterinary Diagnostic Kit (IVD) [Real-Time Polymerase Chain Reaction]	San Group Biotech Germany GmbH	Germany		San Group Biotech Philippines, Inc	San Group Biotech Philippines, Inc	Initial (Vet.)	21 June 2024	21 June 2029

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