| 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
|
-
|
Median Diagnostics Inc.
|
Korea
|
N/A
|
H & B Pharma International Inc.
|
N/A
|
Initial (Vet.)
|
12 December 2022
|
12 December 2024
|
| View |
-
|
VR-MD0054
|
Rapid Canine Parvovirus (CPV) Rapid Antigen Test Kit
|
VDRG CPV Ag Rapid Kit
|
N/A
|
N/A
|
N/A
|
Each box contains: Cassette test kit sealed in Aluminum Foil Bag x 10's + Dropper x 10's + Dilution Buffer x 10's + Cotton Swab x 10's
|
-
|
Median Diagnostics Inc.
|
Korea
|
N/A
|
H & B Pharma International Inc.
|
N/A
|
Initial Vet.]
|
02 March 2023
|
02 March 2025
|
| View |
-
|
VR-MD0055
|
Rapid Ehrlichia canis Antibody Test Kit
|
VDRG E.canis Ab Rapid Kit
|
N/A
|
N/A
|
N/A
|
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.)
|
14 March 2023
|
14 March 2025
|
| View |
-
|
VR-MD0056
|
Rapid Canine Distemper Virus (CDV) Antigen Test Kit
|
VDRG CDV Ag Rapid Kit
|
N/A
|
N/A
|
N/A
|
Each box contains:
Cassette test kit sealed in Aluminum Foil Bag x 10's + PP Bottle containing Dilution Buffer x 10's + Dropper Dropper x 10's+ Cotton Swab x 10's
|
-
|
Median Diagnostics Inc.
|
Korea
|
N/A
|
H & B Pharma International Inc.
|
N/A
|
Initial (Vet.)
|
14 March 2023
|
14 March 2025
|
| View |
-
|
VR-MD0057
|
N/A
|
VDRG CHW Ag Rapid Kit
|
N/A
|
N/A
|
Over-the-Counter (OTC)
|
Each box contains:
Cassette test kit sealed in Aluminum Foil Bag x 10's + PP Tube containing Ethylenediaminetetraacetic acid (EDTA) x 10's+ Dropper x 10's
|
-
|
Median Diagnostics Inc.
|
Korea
|
N/A
|
H & B Pharma International Inc.
|
N/A
|
Initial (Vet.)
|
17 March 2023
|
17 March 2025
|
| 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
|
| View |
-
|
VR-MD0062
|
African Swine Fever Virus (ASFV) Polymerase Chain
Reaction (PCR) Detection Kit
|
Bio-T Kit ASFV Universal
|
N/A
|
N/A
|
Prescription Drug (RX)
|
Each resealable aluminum pouch contains:
Master Mix in Plastic Vial with White Cap x 1.5 mL + Exogenous Internal Positive Control (IC) in Plastic Vial with Pink Cap x 500 μL + External Positive Control (EPC) in Plastic Vial with Orange Cap x 200 μL Water in Plastic Vial with Blue Cap x 1 mL
|
-
|
SAS BioSellal
|
France
|
N/A
|
Golden Bat (Far East) Inc.
|
Golden Bat (Far East) Inc.
|
Initial [Vet.]
|
30 May 2023
|
30 May 2028
|
| View |
-
|
VR-MD0063
|
Canine Immunoglobulin E (IgE) Detection Kit
|
Anitia Canine IgE I
|
None
|
None
|
Prescription Drug (RX)
|
Each set contains:
Test Panels in Aluminum Pouch x 20's + Sample Diluent in Plastic Bottle with Blue Cap x 10 mL + Antibody Solution in Plastic Bottle with Yellow Cap x 10 mL + Enzyme Solution in Plastic Bottle with Red Cap x 10 mL + Substrate Solution in Plastic Bottle with Black Cap x 10 mL + Wash Solution in Plastic Bottle with White Cap x 20 mL (Box 1 set)
|
-
|
ProteomeTech Inc.
|
Korea
|
N/A
|
Diamed Enterprise
|
Diamed Enterprise
|
Initial [Vet.]
|
30 May 2023
|
30 May 2025
|
| View |
-
|
VR-MD0064
|
Needle-free Injector and Spare Parts Kit (Vet.)
|
Hipradermic
|
|
|
Over-the-Counter (OTC)
|
Store at temperatures not exceeding 30°C.
|
-
|
Laboratorios Hipra, S.A.
|
Spain
|
N/A
|
Hipra Philippines, Inc.
|
Hipra Philippines, Inc.
|
Initial (vet.)
|
22 June 2023
|
22 June 2028
|
| View |
-
|
VR-MD0066
|
Subcutaneous Vaccination Device (Vet.)
|
Hipraject
|
NOT APPLICABLE
|
Subcutaneous
|
Over-the-Counter (OTC)
|
Vaccination Device (Injector) with Spare Parts Kit
(Box of 1's)
|
-
|
Laboratorios Hipra, S.A.
|
Spain
|
N/A
|
Hipra Philippines, Inc.
|
Hipra Philippines, Inc.
|
Initial (vet.)
|
06 September 2023
|
06 September 2028
|
| View |
-
|
VR-MD0067
|
N/A
|
Automatic Self-Filling Syringe (Vet.) [HSW Eco-Matic Twin]
|
n/a
|
N/A
|
Over-the-Counter (OTC)
|
2 mL and 0.5 mL Fixed Dose Syringe with Blue Handle, Bottle Mount, Luer Lock Fitting and 5 Position Barrel Swivel x 1's
|
-
|
Henke-Sass, Wolf GmbH
|
Germany.
|
N/A
|
N/A
|
N/A
|
Initial [Vet.]
|
28 November 2023
|
28 November 2028
|
| View |
-
|
VR-MD0068
|
N/A
|
Automatic Self-Filling Syringe (Vet.)
[HSW Eco-Matic]
|
n/a
|
N/A
|
Over-the-Counter (OTC)
|
Each bag contains:
0.5 mL Fixed Dose Syringe with Red Handle, Bottle Mount and Luer Lock Fitting x 1's
|
-
|
Henke-Sass, Wolf GmbH
|
Germany.
|
N/A
|
Ceva Animal Health (Philippines), Inc.
|
N/A
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
-
|
VR-MD0072
|
None
|
Ehrlichia canis Premix Polymerase Chain Reaction (PCR) Detection Kit (Vet.) [Pockit Central Ehrlichia canis Premix]
|
None
|
Freeze Dried
|
Prescription Drug (RX)
|
Each box contains: Freeze Dried Pellet Premix in Vials x 8's (Plastic Bag of 3's) + Positive Control x 4's + Positive Control Buffer x 4's
|
-
|
GeneReach Biotechnology Corporation
|
Taiwan
|
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.)
|
09 January 2024
|
09 January 2027
|
| View |
-
|
VR-MD0073
|
Leptospira sp. Premix Polymerase Chain Reaction
(PCR) Detection Kit (Vet.)
|
Pockit Central Leptospirosis (lipL32) Premix
|
None
|
Freeze Dried
|
Prescription Drug (RX)
|
Each box contains:
Freeze Dried Pellet Premix in Vials x 8's (Plastic Bag of 3's) + Positive Control x 4's+ Positive Control Buffer x 4's
|
Veterinary Medical Device (VMD)
[Polymerase Chain Reaction Amplification-Based Assay]
|
GeneReach Biotechnology Corporation
|
Taiwan
|
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.)
|
12 January 2024
|
10 January 2026
|
| View |
-
|
VR-MD0074
|
Nucleic Acid Extraction and Amplification Kit (Vet.)
|
Pockit™ Central Cartridge Set B
|
None
|
Aqueous
|
Prescription Drug (RX)
|
Each set contains:
FDAY
Extraction Cartridge (B) + Transfer Cartridge (Box of 24 sets)
|
Diagnostic Kit (Veterinary Use Only)
|
GeneReach Biotechnology Corporation
|
Taiwan
|
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.)
|
10 January 2024
|
10 January 2027
|