FDA Verification Portal

× UPDATE! Updated as of 18 August 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-MD0011	Rapid Feline Immunodeficiency Virus (FIV) Ag + Feline Leukemia Virus (Felv) Ag Combined Test Kit (Vet.)	Vetlab Rapid FIV Ab/FelV Ag Combined Test Kit	None	None	Prescription Drug (RX)	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper x l's (Box of 10's) + Dilution Buffer in LDPE Clear Bottle with Yellow Cap x 5 mL + Drop Bottle x 10's + Cotton Swab x 10's	Veterinary Medical Device (IVD) (Qualitative Lateral Flow Immunoassay)	Shenzhen Zhenrui Biotech Co., Ltd.	China	N/A	Healthwinds Medical Trading Corp.	Healthwinds Medical Trading Corp.	Initial (Vet.)	10 May 2022	10 May 2027
View		VR-MD0012	Fowl Laryngotracheitis (LT) Virus Antibody Test Kit	ProFLOK LT AB	NA	NA	Prescription Drug (RX)	Each box contains: LT antigen coated plates in polymer bag x l's (Box of 5's) + 100x positive control in glass bottle x 100 uL + 100x normal control serum in PP bottle x 100 uL + 100x Conjugate Solution in PP amber bottle x 1 mL + Dilution Buffer in HDPE bottle x 200 mL + ABTS Substrate Solution in HDPE bottle x 100 mL + 5x stop solution in HDPE bottle x 25 mL + 20x wash solution in HDPE bottle x 100 mL	Veterinary Medical Device (IVD) Enzyme-Linked Immunosorbent Assay (ELISA)	Zoetis Inc.	U.S.A	N/A	Zoetis Philippines, Inc.	Zoetis Philippines, Inc.	Renewal (Vet.)	17 May 2022	17 May 2027
View		VR-MD0013	Mycoplasmoides gallisepticum (MG) Antibody Test Kit	ProFLOK MG AB	NA	Diagnostic Kit	Prescription Drug (RX)	Each box contains: MG antigen coated plates in polymer bag x l's (Bo of 5's) + 100x positive control in glass bottle x 10 uL + 100x normal control serum in PP bottle x 10 uL + 100x Conjugate Solution in PP amber bottle x mL + Dilution Buffer in HDPE bottle x 200 mL ABTS Substrate Solution in HDPE bottle x 100 mL 5x stop solution in HDPE bottle x 25 mL + 20x was solution in HDPE bottle x 100 mL	Veterinary Medical Device (IVD) Enzyme-Linked Immunosorbent Assay (ELISA)	Zoetis Inc.	U.S.A	N/A	Zoetis Philippines, Inc.	Zoetis Philippines, Inc.	Renewal [Vet.)	10 May 2022	10 May 2027
View		VR-MD0014	Infectious Bronchitis (IB) Virus Antibody Test Kit	ProFLOK IBV AB	NA	NA	Prescription Drug (RX)	Each box contains: IBV antigen coated plates in polymer bag x l’s (Box of 5's) + 100x positive control serum in glass bottle x 100 u L + 100x normal control serum in PP bottle x 100 uL + 100x Conjugate Solution in PP amber bottle x 1 mL + Dilution Buffer in HDPE bottle x 200 mL + ABTS Substrate Solution in HDPE bottle x 100 mL + 5x stop solution in HDPE bottle x 25 mL + 20x wash solution in HDPE bottle x 100 mL	Veterinary Medical Device (IVD) Enzyme-Linked Immunosorbent Assay (ELISA)	Zoetis Inc.	U.S.A	N/A	Zoetis Philippines, Inc.	Zoetis Philippines, Inc.	Renewal (Vet.]	18 May 2022	18 May 2027
View		VR-MD0015	Rapid Fpv Ag Test Kit	Vetlab	None	None	Over-the-Counter (OTC)	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper x l's (Box of 10's) + Dilution Buffer in Polypropylene Bottle with Pink Cap x 0.9 mL + Drop Bottle x 10's + Cotton Swab x 10's	Veterinary Medical Device (IVD) (Qualitative Lateral Flow Immunoassay)	Shenzhen Zhenrui Biotech Co., Ltd.	China	N/A	Health winds Medical Trading Corp.	Health winds Medical Trading Corp.	Initial (Vet.)	19 May 2022	19 May 2027
View		VR-MD0016	Rapid Leptospira IgM Antibody Test Kit (Vet.)	Vetlab Rapid Leptospira IgM Ab Test Kit	None	None	Over-the-Counter (OTC)	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper x l’s (Box of 10's) + Dilution Buffer in LDPE Clear Bottle with Yellow Cap x 5 mL + Drop Bottle x 10's + Cotton Swab x 10's	Veterinary Medical Device (IVD) (Qualitative Lateral Flow Immunoassay)	Shenzhen Zhenrui Biotech Co., Ltd.	China	N/A	Health winds Medical Trading Corp.	Health winds Medical Trading Corp.	Initial (Vet.)	19 May 2022	19 May 2027
View		VR-MD0017	Rapid Giardia Antibody Test Kit (Vet.)	Vetlab Rapid Giardia Ab Test Kit	None	None	Over-the-Counter (OTC)	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper x l’s (Box of 10's) + Dilution Buffer in Polypropylene Bottle x 0.9 mL + Drop Bottle x 10's + Cotton Swab x 10's	Veterinary Medical Device (IVD) (Qualitative Lateral Flow Immunoassay)	Shenzhen Zhenrui Biotech Co., Ltd.	China	N/A	Health winds Medical Trading Corp.	Health winds Medical Trading Corp.	Initial (Vet.)	19 May 2022	19 May 2027
View		VR-MD0018	Rapid Canine Distemper Virus (CDV) Antigen + Canine Adenovirus (CAV) Antigen Test Kit (Vet.)	Vetlab Rapid CDV/CAV Ag Test Kit	None	None	Over-the-Counter (OTC)	Each box contains: Cassette test kit sealed in Aluminum Foil Bag with Dropper x l’s (Box of 10's) + Dilution Buffer in Polypropylene Bottle with Blue Cap x 0.9 mL + Drop Bottle x 10's + Cotton Swab x 10's	Veterinary Medical Device (IVD) (Qualitative Lateral Flow Immunoassay)	Shenzhen Zhenrui Biotech Co., Ltd.	China	N/A	Health winds Medical Trading Corp.	Health winds Medical Trading Corp.	Initial (Vet.)	19 May 2022	19 May 2027
View	-	VR-MD0019	Mesomycoplasma hyopneumoniae (M.hyo) Antibody Test Kit (Vet.)	IDEXX M.Hyo Ab Test	None	Antibody Test Kit (Vet.)	Prescription Drug (RX)	Each set contains: Mh antigen coated plates in Aluminum foil bag x 5's + diluted porcine Mh serum (positive control) x 4 mL + non-reactive anti-porcine HRPO diluted porcine serum x 4 mL + conjugate x 60 mL + diluent x 235 mL + wash concentrate x 235 mL	Veterinary Medical Device (IVD) [Enzyme-linked Immunoassay (ELISA)]	IDEXX Laboratories Singapore Pte. Ltd.	USA		Metro Drug, Inc.	Metro Drug, Inc.	Renewal	13 June 2022	13 June 2027
View		VR-MD0020	Infectious Bronchitis Virus (IBV) Antibody Test Kit (Vet.)	IDEXX IBV Ab Test	None	None	None	Each test kit contains: IBV Antigen Coated Plate 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.)	13 July 2022	13 July 2027
View		VR-MD0021	Avian Influenza (AI) Virus Antibody Test Kit (Vet.)	IDEXX Influenza A Ab Test	None	None	None	Each test kit contains: AI Type A Antigen Coated Plate x 5's + Positive Control x 2 mL + Negative Control x 2 mL + Anti AI: HRPO Conjugate x 55 mL + Diluent x 235 mL,+ TMB Substrate x 60 mL + Stop Solution x 60 mL + Wash Concentrate x 235 mL	Veterinary Medical Device (IVD) [Enzyme-linked Immunoassay (ELISA)]	IDEXX Montipeller SAS	France	N/A	Metro Drug, Inc.	Metro Drug, Inc.	Renewal (Vet.)	21 June 2022	21 June 2027
View		VR-MD0022	Classical Swine Fever (CSF) Virus Antibody Test Kit (Vet.)	IDEXX CSFV Ab Test	None	None	None	Each kit contains: : CSF Antigen Coated Plate x 2's and 5's + Positive Control x 1 mL + Negative Control x 1 mL + Anti CSF: HRPO Conjugate x 20 mL and 60 mL + Diluent x 15 mL and 45 mL + TMB Substrate x 20 mL and 60 mL + Stop Solution x 20 mL and 60 mL + Wash Concentrate x 125 mL and 480 mL in LDPE Bottle	Veterinary Medical Device (IVD) [Enzyme-linked Immunoassay (ELISA)]	IDEXX Laboratories B.V.	Switzerland	N/A	Metro Drug, Inc.	Metro Drug, Inc.	Renewal (Vet.)	23 June 2022	23 June 2027
View		VR-MD0023	Chicken Anemia Virus (CAV) Antibody Test Kit (Vet.)	IDEXX CAV Ab Test	None	None	None	Each test kit contains: CAV Antigen Coated Plate x 5's + Positive Control: Diluted with chicken anti-CAV serum x 2 mL + Negative Control: Diluted with chicken serum non reactive to CAV X 2 mL + Anti-CAV: HRPO Conjugate x 50 mL + Diluent x 235 mL + TMB Substrate x 60 mL + Stop Solution x 60 mL + Wash Concentrate x 235 mL	-	IDEXX Laboratories, Inc.	U.S.A	N/A	Metro Drug, Inc.	Metro Drug, Inc.	Renewal (Vet.)	20 June 2022	20 June 2027
View		VR-MD0024	Newcastle Disease Virus (NDV) Antibody Test Kit	Civtest AVI NDV	Not applicable	Not applicable	None	Each box contains: NDV antigen coated plates in polymer bag x l's (Box of 5's) + Positive Control Serum x 2.2 mL + Negative Control Serum x 2.2 mL + Conjugate Solution x 30 mL + Sample Diluent Solution (10x) x 125 mL + Stop Solution in x 30 mL + Washing Solution (10x) Bottle x 100 mL (Box of 2's) + Substrate Solution in HDPE Bottle x 30 mL	Veterinary Medical Device (IVD) Indirect Enzyme-Linked Immunosorbent Assay (ELISA)	Laboratorios Hipra, S.A.	Spain	N/A	Hipra Philippines, Inc.	Hipra Philippines, Inc.	Renewal [Vet.]	21 June 2022	21 June 2027
View		VR-MD0025	Infectious Bursal Disease (IBD) Antibody Test Kit	ProFLOK IBD PLUS Ab	NA	NA	None	Each box contains: IBD antigen coated plates in polymer bag x 5's + IBD Positive Control Serum in glass bottle x 3cc + Normal Control Serum in PP vial x 5 mL + Goat anti-Chicken IgG (H+L) Peroxidase Conjugate Solution in amber vial x 2mL + 5X Stop Solution x 30 mL + Wash Solution x 30 mL + Dilution Buffer x 250 mL + ABTS x 125 mL in HDPE bottles	Veterinary Medical Device (IVD) Enzyme Linked Immuno Sorbent Assay (ELISA)	Zoetis Inc.	U.S.A	N/A	Zoetis Philippines, Inc.	Zoetis Philippines, Inc.	Renewal correction[Vet.]	03 February 2023	22 June 2027
View		VR-MD0026	Avian Reovirus (ARV) Antibody Test Kit	ProFLOK REO Ab	NA	NA	None	Each box contains: ARV antigen coated plates in polymer bag x 5's + Positive Control in glass bottle x 3cc + Normal Control in PP vial x 5 mL + Conjugate in amber vial x 2mL + 5X Stop Solution x 30 mL + Wash Solution x 30 mL + Dilution Buffer x 250 mL + ABTS x 125 mL in HDPE bottles	Veterinary Medical Device (IVD) Enzyme Linked Immuno Sorbent Assay (ELISA)	Zoetis Inc.	U.S.A	N/A	Zoetis Philippines, Inc.	Zoetis Philippines, Inc.	Renewal [Vet.]	03 February 2023	22 June 2027
View		VR-MD0027	Pseudorabies Virus (PRV) Antigen Test Kit (Vet.)	IDEXX PR/ADV GI Test	None	None	None	Each box contains: PRV Antigen Coated Plate x 6's and 30's + Positive Control x 5 mL + Negative Control x 5 mL + Anti PRV Conjugate x 60 mL and 350 mL + Diluent x 120 mL and 300 mL + TMB Substrate x 60 mL and 315 mL + Stop Solution x 60 mL and 315 mL + Wash Concentrate x 235 mL and 480 mL in LDPE Bottle	Veterinary Medical Device (IVD) [Enzyme-linked Immunoassay (ELISA)]	IDEXX Laboratories, Inc.	U.S.A	N/A	Metro Drug, Inc.	Metro Drug, Inc.	Renewal (Vet.)	23 June 2022	23 June 2027
View		VR-MD0028	Classical Swine Fever (CSF) Virus Antigen Test Kit (Vet.)	IDEXX CSFV Ag Test	None	None	None	Each box contains: Anti-Ems mAb Coated Plate x 2’s and 5's in Polymer Bag + Positive Control x 1.6 mL and 2 mL + Negative Control x 1.6 mL and 2 mL + Conjugate x 25 mL and 60 mL + Tissue Soaking Buffer Concentrate x 115 mL and 45 mL (2’s) + TMB Substrate N.12 x 20 mL and 60 mL + Stop Solution x 20 mL and 60 mL + Wash Concentrate x 125 mL and 480 mL + Detection Solution x 15 mL and 30 mL in LDPE Bottle	Veterinary Medical Device (IVD) [Enzyme-linked Immunoassay (ELISA)]	IDEXX Laboratories, Inc.	U.S.A	N/A	Metro Drug, Inc.	Metro Drug, Inc.	Renewal (Vet.)	24 June 2022	24 June 2027
View		VR-MD0029	Actinobacillus pleuropneumoniae Antibody Test Kit (Vet.)	IDEXX APP Ab Test	None	None	None	Each box contains: APP ApxIV Antigen Coated Plates x 5's + Positive Control x 0.9 mL + Negative Control x 0.9 mL + Conjugate x 60 mL + Diluent x 100 mL + TMB x 60 mL + Stop Solution x 60 mL + Wash Concentrate x 480 mL in LDPE Bottle	Veterinary Medical Device (IVD) [Enzyme-linked Immunoassay (ELISA)]	IDEXX Switzerland AG	Switzerland	N/A	Metro Drug, Inc.	Metro Drug, Inc.	Renewal (Vet.)	28 June 2022	28 June 2027
View		VR-MD0030	Infectious Bursal Disease (IBD) Virus Antibody Test Kit (Vet.)	IDEXX IBD Ab Test	None	None	None	Each box contains: IBD 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.	USA		Metro Drug, Inc.	Metro Drug, Inc.	Renewal	29 June 2022	29 June 2027

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