| View |
|
VR-MD0001
|
Chicken Anemia Virus (CLI Strain) Antibody Test Kit
|
Proflok CAV Ab
|
NA
|
Test Kits
|
Prescription Drug (RX)
|
Each Box contains:
CAV coated Plates Sealed in Polymer Bags (96 weels x 5's), CAV Positive Control Serum (0.1mL x 1's), Normal Control Serum (0.1mL x 1's), Goat anti-Chicken IgG (H+L) Peroxidase Conjugate Solution (1mL x 1's), Dilution Buffer (200mL x 1's), ABTS-Hydrogen Peroxidase Substrate Solution (100 mL x 1's), 5x stop Solution-5% SDS (25mL x 1's) and 20 x wash solution (100mL x 1's)
|
-
|
Zoetis Inc.
|
|
|
Zoetis Philippines Inc.
|
Zoetis Philippines Inc.
|
-
|
28 July 2021
|
28 July 2026
|
| View |
|
VR-MD0002
|
Avian Encephalomyelitis (Van Roekel Strain) Antibody Test Kit
|
ProFLOK AE Ab
|
NA
|
Test Kits
|
Prescription Drug (RX)
|
Each Box contains:
AE Antigen Coated Microplates (96 Weells x 5's), 100x Positove Controls (0.1 mL x 1's), 100x Normal Control (0.1mL x 1's), 100x HRP-Conjugate (1mL x 1's), Dilution Buffer (200mL x 1's), 20x Wash (100mL x 1's), Substrate (100mL x 1's) and 5x Stop Solution-5% SDS (25mL x 1's)
|
-
|
Zoetis Inc.
|
|
|
Zoetis Philippines Inc.
|
Zoetis Philippines Inc.
|
-
|
28 July 2021
|
28 July 2026
|
| View |
|
VR-MD0003
|
Mycoplasma Synoviae Antibody Test Kit
|
Proflok Ms Ab
|
NA
|
Test Kits
|
Prescription Drug (RX)
|
Each box contains:
Microplates (96 wells x 5's), Positive Control 100X Preserved in Thimerosal (0.1 mLx l's), Normal Control 100X preserved in Thimerosal (0.1 mL xl's), HRP-Conjugate 100X Preserved with Microcide III (1 mL xl's), Dilution Buffer Plus (200 mL xl's), Wash 20X;preserved with Imidazole (100 mL X l's), Substrate (100 mL x l's) and 5X Stop (5% SDS) (25 mL xl's)
|
-
|
Zoetis Inc.
|
USA
|
|
Zoetis Philippines, Inc.
|
Zoetis Philippines, Inc.
|
Renewal (Vet.)
|
06 August 2021
|
06 August 2026
|
| View |
-
|
VR-MD0004
|
African Swine Fever (ASF) Polymerase Chain
Reaction (PCR) Detection Kit
|
GenAmplify
|
N/A
|
N/A
|
Household Remedy (HR)
|
Each set contains:
ASF Multiplex Mastermix in 2 mL PP Vial x 780 uL, Positive Control in 2 mL PP Vial x 200 ul and Nuclease-free Water in 2 mL PP vial x 300 uL
(Box of 1 set)
|
Veterinary Medical Device (VMD)
Quantitative Polymerase Chain Reaction (PCR)
Amplification-Based Assay
|
Manila Health Tek, Inc.
|
Philippines
|
|
|
|
Initial [Vet. ]
|
12 October 2021
|
12 October 2026
|
| View |
|
VR-MD0005
|
Infectious Bursal Disease (IBD) Virus Antibody Test Kit
|
ProFLOK IBD AB
|
NA
|
Diagnostic Kit
|
Prescription Drug (RX)
|
Each box contains:
IBD antigen coated plates in polymer bag x l's (Box of 5's) + 100x positive control serum in glass bottle x 100 uL + 100x Normal control serum in PP bottie 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.]
|
06 May 2022
|
06 May 2027
|
| View |
|
VR-MD0006
|
Avian Influenza Virus (AIV) Type A Antigen Test Kit
|
FluDETECT Avian
|
NA
|
Test Kits
|
Prescription Drug (RX)
|
Each box contains:
Test strips in polymer vial x 20's + Extraction Buffer in PP vial x 6 mL + PE test tube with cap x 20's + Cotton swabs x 20's + Test tube rack x1's
|
Veterinary Medical Device (IVD)
Enzyme-Linked Immunosorbent Assay (ELISA)
|
Zoetis Inc.
|
U.S.A
|
N/A
|
Zoetis Philippines, Inc.
|
Zoetis Philippines, Inc.
|
Renewal [Vet.]
|
06 May 2022
|
06 May 2027
|
| View |
|
VR-MD0007
|
Newcastle Disease (ND) Virus Antibody Test Kit
|
ProFLOK NDV AB
|
NA
|
Diagnostic Kit
|
Prescription Drug (RX)
|
Each box contains:
NDV antigen coated plates in polymer bag x l's (Box of 5's) + NDV positive control serum in glass bottle x 100 uL + Negative control serum in PP bottle x 100 uL + Goat anti-Chicken IgG (H+L) Peroxidase Conjugate Solution in PP amber bottle x 1 mL + Dilution Buffer in HDPE bottle x 200 mL + ABTS Hydrogen peroxide 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.]
|
06 May 2022
|
06 May 2027
|
| View |
|
VR-MD0008
|
Avian Influenza Virus (AIV) Antibody Test Kit
|
ProFLOK AIV AB
|
NA
|
Diagnostic Kit
|
Prescription Drug (RX)
|
Each box contains:
AIV antigen coated plates in polymer bag x l's (Box of 5's) + AIV positive control serum in glass bottle x 100 uL + Negative control serum in PP bottle x 100 uL + Peroxidase Conjugate Solution in PP amber bottle x 1 mL + Dilution Buffer in HDPE bottle X 200 mL + ABTS-Hydrogen Peroxide Substrate Solution in HDPE bottle x 100 mL + 5x stop solution, 5% SDS 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.]
|
06 May 2022
|
06 May 2027
|
| View |
|
VR-MD0009
|
Rapid Canine Corona Virus (CCV) Ab + Canine
Parvovirus (CPV) Ab + Giardia Ab Combined Test
Kit (Vet.)
|
Vetlab Rapid CCV/CPV/GIA 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 Polypropylene Vial x 0.9 mL (Box of 10's) + 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-MD0010
|
Rapid Heartworm + Ehrlichia Ag + Babesia Ag +
Anaplasma Ag Combined Test Kit (Vet.)
|
VetLab Rapid CHW/Ehr/Lyme/Anaplasma 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-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
|