FDA Verification Portal

× UPDATE! Updated as of 31 March 2025.

	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-MD0038	Infectious Bronchitis (IB) Virus Antibody Test Kit	CIVTEST Avi IBV	Not applicable	Not applicable	None	Each box contains: IBV antigen coated plates in polymer bag x 5's + Positive Control x 2.2 mL + Negative Control x 2.2 mL + Conjugate x 30 mL + Stop Solution x 30 mL + Wash Solution x 125 mL + Dilution Buffer x 125 mL + ABTS solution x 30 mL in HDPE bottles	Veterinary Medical Device (IVD) Enzyme Linked Immuno Sorbent Assay (ELISA)	Laboratorios Hipra, S.A	Spain		Hipra Philippines, Inc.	Hipra Philippines, Inc.	Renewal (Vet.)	07 July 2022	07 July 2027
View		VR-MD0039	Infectious Bursal Disease (IBD) Virus Antibody Test Kit	CIVTEST Avi IBD	Not applicable	Not applicable	Not applicable	Each box contains: IBDV antigen coated plates in polymer bag x 5's + Positive Control x 2.2 mL + Negative Control x 2.2 mL + Conjugate x 30 mL + Stop Solution x 30 mL + Wash Solution x 125 mL + Dilution Buffer x 125 mL + ABTS solution x 30 mL in HDPE bottles	-	Laboratorios Hipra, S.A	Spain		Hipra Philippines, Inc.	Hipra Philippines, Inc.	Renewal (Vet.)	07 July 2022	07 July 2027
View		VR-MD0040	African Swine Fever (ASF) Virus DNA Mix Test Kit (Vet.)	IDEXX RealPCR ASFV DNA Mix	None	None	None	Each box contains: ASFV DNA Mix x 1 mL + DNA Master Mix x 1 mL + Positive Control x 0.5 mL + PCR Grade Water x 1 mL (2’s) in LDPE Vials	Veterinary Medical Device (IVD)	IDEXX Montpellier SAS	France	N/A	Metro Drug, Inc.	Metro Drug, Inc.	Renewal (Vet.)	05 July 2022	05 July 2027
View		VR-MD0041	Mycoplasmoides gallisepticum (Mg) Antibody Test Kit (Vet.)	IDEXX MG Ab Test	None	None	None	Each box contains: Mg Antigen Coated Plates in Polymer Bag x 5's + Positive Control x 1.9 mL + Negative Control x 1.9 mL + HRPO Conjugate x 50 mL + Diluent x 235 mL + TMB Substrate x 60 mL + Stop Solution x 60 mL in LDPE Bottles	Veterinary Medical Device (IVD) [Enzyme-Linked Immunoassay (ELISA)]	IDEXX Laboratories, Inc.	U.S.A	N/A	Metro Drug, Inc.	Metro Drug, Inc.	Renewal (Vet.)	05 July 2022	05 July 2027
View		VR-MD0042	Turkey Rhinotracheitis (TRT) Virus Antibody Test Kit	CIVTEST Avi TRT	N/A	N/A	None	Each box contains: TRT antigen coated plates in eight well strips x 5's + Positive Control x 2.2 mL + Negative Control x 2.2 mL + Conjugate x 30 mL + Stop Solution x 30 mL + Wash Solutions (2) x 100 mL + Dilution Buffer x 125 mL + ABTS solution x 30 mL in HDPE bottles	Veterinary Medical Device (IVD) Enzyme Linked Immunosorbent Assay (ELISA)	Laboratorios Hipra, S.A	Spain	N/A	Hipra Philippines, Inc.	Hipra Philippines, Inc.	Renewal [Vet.)	19 July 2022	19 July 2027
View		VR-MD0043	Egg Drop Syndrome (EDS-76) Virus Antibody Test Kit	CIVTEST AVI EDS	N/A	N/A	None	Each box contains: EDS antigen coated plates in eight well strips x 5's + + Conjugate x 30 mL + Stop Solution x 30 mL + Wash Solutions (2) x 100 mL + Dilution Buffer x 125 mL + ABTS solution x 30 mL in HDPE Bottles	Veterinary Medical Device (IVD) Enzyme Linked Immuno Sorbent Assay (ELISA)	Laboratorios Hipra, S.A	Spain	N/A	Hipra Philippines, Inc.	Hipra Philippines, Inc.	Renewal [Vet.)	19 July 2022	19 July 2027
View		VR-MD0044	Ehrlichia canis Antibody Test Kit	Vetlab	None	None	None	Each box contains: Plastic containing E. canis antigen in a foil pouch x 10's, dilution buffer x l's, dropper x 10's in HDPE bottles	-	Shenzhen Zhenrui Biotech Co., Ltd	China		Healthwinds Medical Trading Corp.	Healthwinds Medical Trading Corp.	Renewal [Vet.)	27 July 2022	27 July 2027
View		VR-MD0045	Toxoplasma gondii Antibody Test Kit	Vetlab	None	None	None	Each box contains: Plastic cassette containing Toxoplasma gondii antibody in a foil pouch x 10's, dropper x 10's	Veterinary Medical Device (IVD) Immunochromatographic Assay (ICA)	Shenzhen Zhenrui Biotech Co., Ltd	China		Healthwinds Medical Trading Corp.	Healthwinds Medical Trading Corp.	Renewal Vet	28 July 2022	28 July 2027
View		VR-MD0046	Canine Heartworm (Dirofilaria immitis) Antigen Test Kit	Vetlab	None	None	None	Each box contains: Plastic cassette containing Canine Heartworm (Dirofilaria immitis) antigen in a foil pouch x 10's, dilution buffer x l's, dropper x 10's in HDPE bottles	Veterinary Medical Device (IVD) Immunochromatographic Assay (ICA)	Shenzhen Zhenrui Biotech Co., Ltd	China		Healthwinds Medical Trading Corp.	Healthwinds Medical Trading Corp.	Renewal [Vet.)	27 July 2022	27 July 2027
View		VR-MD0047	Rapid Canine Distemper Virus (CDV) Antigen Test Kit	Vetlab Rapid CDV Ag Test Kit :	None	None	None	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper x l's (Box of 10's) + Dilution Buffer in PP Bottle with Blue Cap x 0.9 mL (Box of 10's) + Cotton Swab x 10's	Veterinary Medical Device (IVD) [Immunochromatographic Assay]	Shenzhen Zhenrui Biotech Co., Ltd.	China		Healthwinds Medical Trading Corp	Healthwinds Medical Trading Corp	Initial [Vet]	31 August 2022	31 August 2027
View		VR-MD0048	Canine Parvovirus (CPV) Antigen Test Kit	Vetlab Rapid CPV Ag Test Kit	None	None	None	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper x l's (Box of 10's) + Dilution Buffer in PP Bottle with Pink Cap x 0.9 mL (Box of 10's) + Cotton Swab x 10's + Disposable Gloves x 4's	-	Shenzhen Zhenrui Biotech Co., Ltd.	China		Healthwinds Medical Trading Corp	Healthwinds Medical Trading Corp	Initial \|Vet.]	31 August 2022	31 August 2027
View		VR-MD0049	Rapid Feline Coronavirus (FCV) Antigen Test Kit	Vetlab Rapid FCOV Ag Test Kit	None	None	None	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper xl's (Box of 10's) + Dilution Buffer in PP Bottle with Pink Cap x 0.9 mL (Box of 10's) + Cotton Swab x 10's + Disposable Gloves x 4's	-	Shenzhen Zhenrui Biotech Co., Ltd.	China		Healthwinds Medical Trading Corp	Healthwinds Medical Trading Corp	Initial (Vet.]	31 August 2022	31 August 2027
View		VR-MD0050	Bluetongue Virus Antibody Test Kit	VMRD Bluetongue	NA	NA	None	Each box contains: Antigen coated plates in mylar pouches (Box of 2's and 5's) + Positive Control x 4 mL + Negative Control x 4 mL + Antibody-Peroxidase Conjugate x 16 mL + 50x Wash Solution Concentrate x 60 mL + Substrate Solution x 30 mL + Stop Solution x 30 mL	Veterinary Medical Device (IVD) [Enzyme-Linked Immunosorbent Assay (ELISA)]	VMRD, Inc.	United States of America	N/A	Advira Trading Corporation	Advira Trading Corporation	Initial [Vet.] correcttion	23 September 2022	01 September 2027
View		VR-MD0051	Small Ruminant Lentivirus Antibody Test Kit	VMRD Small Ruminant	NA	NA	None	Each box contains: Antigen coated plates in mylar pouches x l's (Box of 5's) + positive control x 3.6 mL + negative control x 3.6 mL + 100x Antibody-Peroxidase Conjugate x 500 uL + Conjugate Diluting Buffer x 60 mL + 10x Wash Solution Concentrate x 120 mL (Box of 2's) + Substrate Solution x 60 mL + Stop Solution x 60 mL	Veterinary Medical Device (IVD) [Enzyme-Linked Immunosorbent Assay (ELISA)]	VMRD, Inc.	United States of America				Initial [Vet.] correcttion	11 November 2022	01 September 2027
View		VR-MD0052	Equine Infectious Anemia (EIA) Virus Immunodiffusion Test	VMRD Equine	NA	NA	None	Each box contains: EIA Virus p26 Antigen x 3.35 mL + Reference Positive Control Serum x 10 mL	Veterinary Medical Device (IVD) [Agar-Gel Immunodiffusion (AGID) Test]	VMRD, Inc.	United States of America	N/A	Advira Trading Corporation	Advira Trading Corporation	Initial [Vet.] correcttion	23 September 2022	01 September 2027
View	-	VR-MD0053	Rapid Canine Corona Virus (CCV) and Canine Parvovirus (CPV) Antigen Test Kit	VDRG CCV/CPV Ag	N/A	N/A	N/A	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper x 10's+ Dilution Buffer (Box of 10's) + Cotton Swab x 10's	Veterinary Medical Device (IVD) [Immunochromatographic Immunoassay]	Median Diagnostics Inc.	Korea	N/A	H & B Pharma International Inc.	N/A	Renewal	06 January 2025	12 December 2029
View	-	VR-MD0058	Rapid Feline Leukemia Virus (FeLV) Antigen and Feline Immunodeficiency Virus (FIV) Antibody Test Kit	VDRG FeLV Ag/FIV Ab	None	None	None	Each box contains: Cassette test kit sealed in Aluminum Foil Bag x 10's +PP Tube containing Ethylenediaminetetraacetic acid (EDTA) x 10's+ PP Bottle containing Dilution Buffer x 3 mL + Capillary Tuber x 10's	-	Median Diagnostics Inc.	Korea	N/A	H & B Pharma International Inc.	N/A	Initial [Vet.]	09 May 2023	09 May 2025
View	-	VR-MD0059	Rapid African Swine Fever Virus (ASFV) Antigen Kit	Pencheck	N/A	N/A	Prescription Drug (RX)	Each box contains: Test Strips in White Tube x 50's + PP Vials in Resealable Bag x 50's + Test Vial Holder x 1's	-	Silver Lake Research Corp	U.S.A.	N/A	BioAssets Corporation	BioAssets Corporation	Initial [Vet.]	25 May 2023	25 May 2025
View	-	VR-MD0060	African Swine Fever Virus (ASFV) Polymerase Chain Reaction Detection Kit	Virotype Asfv 2.0 PCR Kit			Prescription Drug (RX)	Master Mix in Plastic Vial with Orange Cap x 980 μL (Box of 2's) IC-DNA in Plastic Tube with Clear Cap x 200 μL + Positive Control in Plastic Tube with Red Cap x 150 μL + Negative Control in Plastic Tube with Blue Cap x 150 μL (Box of 1 set)	-	Indical Bioscience GmbH	Germany	N/A	BioAssets Corporation	BioAssets Corporation	Initial [Vet.]	30 May 2023	30 May 2025
View	-	VR-MD0061	Rapid Avian Influenza Virus (AIV) Antigen Test Kit	RIDXTM AIV Ag Test Kit	N/A	N/A	Prescription Drug (RX)	Cassette Test Kit in Resealable Aluminum Pouch x 10's (Box of 3's)+ Dilution Buffer in Plastic Tube x 1 mL (Box of 30's)+ Cotton Swab x 30's + Dropper Cap in Plastic Container x 10's (Box of 3's)	-	Skyer Inc.	Korea	N/A	GenAmplify Technologies Inc.	GenAmplify Technologies Inc.	Initial [Vet.]	30 May 2023	30 May 2025

All