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
|