| View |
-
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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
|
| View |
-
|
VR-MD0075
|
Canine Distemper Virus (CDV) Polymerase Chain
Reaction (PCR) Detection Kit (Vet.)
|
Pockit™ Central Cdv 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 Diagnostic Reagent
|
GeneReach Biotechnology Corporation
|
Taiwan
|
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.)
|
10 January 2024
|
10 January 2027
|
| View |
-
|
VR-MD0076
|
Babesia canis + Babesia gibsoni Polymerase Chain
Reaction (PCR) Detection Kit (Vet.)
|
Pockit™ Central Canine Babesiosis 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) A
[Polymerase Chain Reaction Amplification-Based Assay]
|
GeneReach Biotechnology Corporation
|
Taiwan
|
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.)
|
10 January 2024
|
10 January 2027
|
| View |
-
|
VR-MD0077
|
N/A
|
Needle Free Intradermal Vaccination Device (Vet.) [Idal 3G+ Mono]
|
N/A
|
Battery-Operated Intra-Dermal Vaccination Device
|
Prescription Drug (RX)
|
Each Box contains: Needle Free Intradermal Vaccination Device x 1's + Charger + Batteries x 2's + Rinsing Flui x 2's
|
-
|
Henke-Sass Wolf GmbH
|
Germany
|
|
MSD Animal Health (Phils.), Inc.
|
MSD Animal Health (Phils.), Inc.
|
Initial (Vet.)
|
09 January 2024
|
09 January 2029
|
| View |
-
|
VR-MD0078
|
Needle Free Intradermal Vaccination Device (Vet.)
|
Idal 3G+ Twin
|
N/A
|
Battery-Operated Intra-Dermal Vaccination Device
|
Prescription Drug (RX)
|
Each box contains:
Needle Free Intradermal Vaccination Device x 1'
Charger Batteries x 2's+ Rinsing Fluid x 2's
|
Veterinary Medical Device
|
Henke-Sass Wolf GmbH
|
Germany
|
|
MSD Animal Health (Phils.), Inc.
|
MSD Animal Health (Phils.), Inc.
|
Initial (Vet.)
|
10 January 2024
|
10 January 2029
|
| View |
-
|
VR-MD0079
|
Mycobacterium avium subsp. Paratuberculosis (MAP)
|
Vmrd Map
|
NA
|
Test Kit
|
Prescription Drug (RX)
|
Each box contains:
Antigen Coated Plate x 2's+ Positive Control x 4 mL +
Posit Negative Control x 4 mL + Peroxidase Conjugate x 16 mL Sample Diluting Buffer x 60 mL 10x Wash Solution Concentrate x 120 mL + Substrate Solution x 30 mL Stop Solution x 30 mL; and
Antigen Coated Plate x 5's+ Positive Control x 4 mL + Negative Control x 4 mL + Peroxidase Conjugate x 40 mL + Sample Diluting Buffer x 60 mL (Box of 2's) + 10x Wash Solution Concentrate x 120 mL (Box of 2's) + Substrate
rate Solution x 60 mL + Stop Solution x 60 mL
|
Veterinary Diagnostic Kit (IVD) [Enzyme-Linked Immunosorbent Assay]
|
VMRD, Inc
|
U.S.A.
|
|
Advira Trading Corporation
|
Advira Trading Corporation
|
Initial (Vet.)
|
09 January 2024
|
09 January 2029
|
| View |
-
|
VR-MD0080
|
Id Screen® Mvv / Caev Indirect
|
Maedi-Visna Virus (MVV) +
Caprine Arthritis.
Encephalitis Virus (CAEV) Antibody Test Kit (Vet.)
|
N/A
|
Diagnostic Reagent/Kit
|
Over-the-Counter (OTC)
|
Each box contains:
ze DA,
Coated Microplates x 5's + Positive Control x 1 mL + Negative Control x 1 mL + Dilution Buffer 16 x 60 mL Conjugate 10x x 6 mL + Dilution Buffer 3. x 60 mL + Wash Solution 20x x 60 mL + Substrate Solution x 60 mL + Stop Solution x 60 mL
|
Veterinary Diagnostic Kit (IVD)
|
Innovative Diagnostics SARL
|
France
|
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
09 January 2024
|
09 January 2026
|
| View |
-
|
VR-MD0081
|
Id Screen® Influenza H5 Antibody Competition
|
Avian Influenza A Virus H5 Antibody Test Kit (Vet.)
|
N/A
|
Diagnotics Kit
|
None
|
Each box contains:
Coated Microplates x 2's + Positive Control x 1 mL + Negative Control x 1 mL + Dilution Buffer 14 x 60 mL + Conjugate 10x x 3 mL + Dilution Buffer 3 x 60 mL Wash Solution 20x x 60 mL + Substrate Solution x 60 mL Stop Solution x 60 mL; and
FDA
Coated Microplates x 5's+ Positive Control x 1 mL (Box of 2's) Negative Control x 1 mL (Box of 2's) + Dilution Buffer 14 x 60 mL + Conjugate 10x x 3 mL (Box of 2's) + Dilution Buffer 3 x 60 mL Wash Solution 20x x 60 mL + Substrate Solution x 60 mL + Stop Solution x 60 mL
|
Veterinary Diagnostic Kit
|
INNOVATIVE DIAGNOSTICS
|
France
|
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
09 January 2024
|
09 January 2029
|
| View |
-
|
VR-MD0082
|
None
|
Avian Infectious Laryngotracheitis (ILT) Virus Antibody Test Kit (Vet.)
|
N/A
|
N/A
|
N/A
|
Each box contains:
Coated Microplates x 5's+ Positive Control x 3.5 mL + Negative Control x 3.5 mL + Dilution Buffer 14 x 60 mL (Box of 3's) + Conjugate 10x x 7 mL + Dilution Buffer 3 x 60 mL + Wash Solution 20x x 60 mL + Substrate Solution x 60 mL + Stop Solution x 60 mL; and
Coated Microplates x 10's+ Positive Control x 3.5 mL (Box of 2's) Negative Control x 3.5 mL (Box of 2's) + Dilution Buffer 14 x 60 mL (Box of 5's)+ Conjugate 10x x 7 mL (Box of 2's)+ Dilution Buffer 3 x 60 mL (Box of 2's)+ Wash Solution 20x x 60 mL (Box of 2's)+ Substrate Solution x 60 mL (Box of 2's) + Stop Solution x 60 lution x 60 mL (Box of 2's)
|
Veterinary Diagnostic Kit (IVD)
[Enzyme-Linked Immunosorbent Assay]
|
Innovative Diagnostics SARL
|
France
|
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
31 January 2024
|
31 January 2026
|
| View |
-
|
VR-MD0083
|
None
|
African Swine Fever Virus (ASFV) Antibody Test Kit
(Vet.)
|
N/A
|
None
|
N/A
|
Each box contains: Coated Microplates x 2's+ Positive Control x 1 mL + Negative Control x 1 mL + Dilution Buffer 14 x 60 mL + Conjugate 10x x 6 mL + Dilution Buffer 3 x 60 mL + Wash Solution 20x x 60 mL + Substrate Solution x 60 mL Stop Solution x 60 mL; and
Coated Microplates x 5's Positive Control x 1 mL + Negative Control x 1 mL + Dilution Buffer 14 x 60 mL (Box of 2's) + Conjugate 10x x 6 mL + Dilution Buffer 3 x 60 mL + Wash Solution 20x x 60 mL + Substrate Solution x 60 mL + Stop Solution x 60 mL
|
Veterinary Diagnostic Kit (IVD)
[Enzyme-Linked Immunosorbent Assay]
|
Innovative Diagnostics SARL
|
France
|
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
30 January 2024
|
30 January 2026
|
| View |
-
|
VR-MD0084
|
N/A
|
Avian Infectious Laryngotracheitis (ILT) Virus Antibody
Test Kit (Vet.)
|
N/A
|
N/A
|
N/A
|
Do not freeze Each box contains:
Coated Microplates x 5's+ Positive Control x 3.5 mL + Negative Control x 3.5 mL + Dilution Buffer 14 x 60 mL (Box of 3's) + Conjugate 10x x 7 mL + Dilution Buffer 3 x 60 mL + Wash Solution 20x x 60 mL + Substrate Solution x 60 mL + Stop Solution x 60 mL;
60 mL and
Coated Microplates x 10's+ Positive Control x 3.5 mL (Box of 2's) + Negative Control x 3.5 mL (Box of 2's) + Dilution Buffer 14 x 60 mL (Box of 5's)+ Conjugate 10x x 7 mL (Box of 2's) + Dilution Buffer 3 x 60 mL (Box of 2's) + Wash Solution 20x x 60 mL (Box of 2's)+ Substrate Solution x 60 mL (Box of 2's) + Stop Solution x 60 mL (Box of 2's)
|
Veterinary Diagnostic Kit (IVD) [Enzyme-Linked Immunosorbent Assay]
|
Innovative Diagnostics SARL
|
France
|
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
31 January 2024
|
31 January 2026
|