| View |
-
|
VR-MD0122
|
Canine Parvovirus (CPV) Antigen Detection Kit (Vet.)
|
Rapigen Canine Parvovirus Ag Test
|
N/A
|
N/A
|
N/A
|
Each box contains:
Test Device in Aluminum Pouch + Assay Diluent Tube x 0.7 mL + Filter Cap + Cotton Swab (Box of 10's)
|
Veterinary Diagnostic Kit (IVD) (Immunochromatographic Assay)
|
Rapigen, Inc.
|
Korea
|
|
Broadchem Philippines Biopharma Corporation
|
Broadchem Philippines Biopharma Corporation
|
Initial (Vet.)
|
05 June 2024
|
05 June 2029
|
| View |
-
|
VR-MD0123
|
Canine Heartworm (CHW) Antigen Detection Kit (Vet.)
|
Rapigen Canine Heartworm Ag Test
|
N/A
|
N/A
|
N/A
|
Each box contains:
Test Device in Aluminum Pouch x 10's + Assay Buffer Bottle x 3 mL + Dropper x 10's
|
Veterinary Diagnostic Kit (IVD)
(Immunochromatographic Assay)
|
Rapigen, Inc.
|
Korea
|
|
Broadchem Philippines Biopharma Corporation
|
Broadchem Philippines Biopharma Corporation
|
Initial (Vet.)
|
05 June 2024
|
05 June 2029
|
| View |
-
|
VR-MD0124
|
Porcine Circovirus (PCV) Genotype 2a, 2b and 2d
Polymerase Chain Reaction (PCR) Detection Kit (Vet.)
|
Kylt PCV-2 Typing
|
None
|
None
|
None
|
Each box contains:
Reaction Mix in PP vial with Brown Cap x 450 μL + Positive Control in PP vial with Red Cap x 2's + Negative Control in PP vial with Blue Cap x 1 mL; and
Reaction Mix in PP vial with Brown Cap x 450 μL (Box of 4's) Positive Control in PP vial with Red Cap x 4's + Negative Control in PP vial with Blue Cap x 1 mL
|
Veterinary Diagnostic Kit (IVD)
[Real-Time Polymerase Chain Reaction]
|
San Group Biotech Germany GmbH
|
Germany
|
|
San Group Biotech Philippines, Inc
|
San Group Biotech Philippines, Inc
|
Initial (Vet.)
|
21 June 2024
|
21 June 2029
|
| View |
-
|
VR-MD0125
|
Salmonella spp Polymerase Chain Reaction (PCR)
Detection Kit (Vet.)
|
Kylt Salmonella spp 2.0
|
NA
|
Na
|
Na
|
Each box contains:
Reaction Mix in PP vial with Brown Cap x 450 μl (Box of 4's) + Positive Control in PP vial with Red Cap x 2's + Negative Control in PP vial with Red Cap x 1 mL
|
Veterinary Diagnostic Kit (IVD)
[Real-Time Polymerase Chain Reaction]
|
San Group Biotech Germany GmbH
|
Germany
|
|
San Group Biotech Philippines, Inc
|
San Group Biotech Philippines, Inc
|
Initial (Vet.)
|
21 June 2024
|
21 June 2029
|
| View |
-
|
VR-MD0126
|
Mycoplasma_gallisepticum and Mycoplasma synoviae
Polymerase Chain Reaction (PCR) Detection Kit (Vet.)
|
Kylt MGS Triplex
|
None
|
None
|
None
|
Each box contains:
Reaction Mix in PP vial with Brown Cap x 450 μl + Positive Control in PP vial with Red Cap x 2's + Negative Control in PP vial with Blue Cap x 1 mL; and
Reaction Mix in PP vial with Brown Cap x 450 μl (Box of 4's) Positive Control in PP vial with Red Cap x 4's + Negative Control in PP vial with Blue Cap x 1 mL
|
Veterinary Diagnostic Kit (IVD)
[Real-Time Polymerase Chain Reaction]
|
San Group Biotech Germany GmbH
|
Germany
|
|
San Group Biotech Philippines, Inc
|
San Group Biotech Philippines, Inc
|
Initial (Vet.)
|
21 June 2024
|
21 June 2029
|
| View |
-
|
VR-MD0127
|
Classical Swine Fever (CSF) Virus Polymerase Chain
Reaction (PCR) Detection Kit
|
Adialyo CSFV
|
None
|
None
|
None
|
Each box contains:tween 2-3
Vial containing Freeze Dried Amplification Solution x 1's+ Rehydration Buffer x 6 mL + CSFV Positive Control in PP vial with Purple Cap x1000 μL + Nuclease- Free Water in PP vail with White Cap x 1000 μL
|
Veterinary Diagnostic Kit (IVD)
[Polymerase Chain Reaction Amplification-Based Assay]
|
Bio-X Diagnostics S.A
|
Belgium
|
|
Jann Animal Health and Nutrition, Inc.
|
Jann Animal Health and Nutrition, Inc.
|
Initial (Vet.)
|
11 July 2024
|
11 July 2029
|
| View |
-
|
VR-MD0129
|
Coxiella burnetii Polymerase Chain Reaction (PCR)
Diagnostic Kit (Vet.)
|
None
|
N/A
|
N/A
|
N/A
|
Quantified Synthetic Plasmid in vial with Blue Cap x 50 μL + Freeze-Dried Non-Target Positive Control x 2200 μL x Amplification Reaction Mix in vial with White Cap x 400 μL + Freeze-Dried Target Positive Control x 550 μL; and Quantified Synthetic Plasmid in vial with Blue Cap x 50 μL Freeze-Dried Non-Target Positive Control x 2200 μL + Amplification Reaction Mix (400 μL) in vial with White Cap x 2's+ Freeze-Dried Target Positive Control x 550 μL
|
Veterinary Medical Device (IVD)
[Polymerase Chain Reaction Amplification Based Assay]
|
Innovative Diagnostics
|
France
|
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.) (Vet)
|
13 September 2024
|
13 September 2026
|
| View |
-
|
VR-MD0128
|
African Swine Fever (ASF) Virus Polymerase Chain Reaction (PCR) Detection Kit (Vet.)
|
SBC ASFV CPCR Kit
|
N/A
|
N/A
|
N/A
|
Each box contains:
Reagent A (80 μL) in PP vial with Blue Cap x 6's + Reagent B (176 μL) in PP vial with Green Cap x 6's + Reagent C (224 μL) in PP vial with Red Cap x 6's + Dilution Buffer (800 μL) in PP vial with Yellow Cap x
6's
Freeze-Dried Positive Control in PP vial with Brown Cap x 1's Positive Control Reconstitution Buffer with Orange Cap x 100 μL + Negative Control in PP vial with White Cap x 100 μL
|
Veterinary Diagnostic Kit (IVD) (Polymerase Chain Reaction)
|
Schweitzer Biotech Company Ltd.
|
Taiwan
|
|
Terra Agua Regional Distribution and Integrated Solutions. (T.A.R.D.I.S.) Inc.
|
Terra Agua Regional Distribution and Integrated Solutions. (T.A.R.D.I.S.) Inc.
|
Initial (Vet.)
|
11 September 2024
|
11 September 2029
|
| View |
-
|
VR-MD0130
|
Coxiella burnetii Phase I and II Antibody Detection Kit
(Vet:)
|
None
|
N/A
|
N/A
|
N/A
|
Each box contains:
Coated Microplate x 2's+ Positive Control x 1 mL + Negative Control x 3.5 mL + Dilution Buffer 2 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
Coated Microplate x 5's+ Positive Control 1 mL + Negative Control x 3.5+ Dilution Buffer 2 x 60 mL (Box of 3's) + Conjugate 10x x 3 mL (Box of 2's) + Dilution Buffer 3 x 60 mL + Wash Solution 20x x 60 mL (Box of 2's) + Substrate Solution x 60 mL + Stop Solution x 60 mL
|
Veterinary Medical Device (IVD)
[Enzyme-Linked Immunosorbent Assay]
|
Innovative Diagnostics
|
France
|
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
13 September 2024
|
13 September 2026
|
| View |
-
|
VR-MD0139
|
African Swine Fever Virus Antigen Rapid Test Kit
|
Vetdiagnostix
|
None
|
None
|
Prescription Drug (RX)
|
Each box contains:Cassette Test Device in Aluminum Pouch x 1's (Box of 10's)+ Disposable Droppers + Assay Buffer x 1's
|
Veterinary Diagnostic Kit (IVD) (Immunochromatographic Assay)
|
Hangzhou Evegen Biotech Co., Ltd.
|
China
|
N/A
|
Vetdiagnostix Corp.
|
Vetdiagnostix Corp.
|
Initial (Vet.)
|
26 September 2024
|
26 September 2026
|
| View |
-
|
VR-MD0147
|
None
|
Porcine Reproductive and Respiratory Syndrome (PRRS) Virus RNA Polymerase Chain Reaction (PCR) Detection
hain R Kit (Vet.)
|
N/A
|
Diagnostic Reagent/Kit
|
Over-the-Counter (OTC)
|
Positive Amplification Control in vial with Blue Cap x
trol in 100 μL + Exogenous Non-Target Positive Control in vial with Green Cap x 2.2 mL x + Amplification Reaction Mix in vial with White Cap x 400 μL; and
Positive Amplification Control in vial with Blue Cap x 100 μL + Exogenous Non-Target Positive Control x 2.2 mL x + Amplification Reaction Mix in vial with White Cap x 400 μL (Box of 2's)
|
Veterinary Diagnostic KiT (IVD) { Polymerase Chain Reaction Amplification Based Assay}
|
Innovative Diagnostics SARL
|
France
|
N/A
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
16 January 2025
|
16 January 2027
|
| View |
-
|
VR-MD0149
|
N/A
|
Progesterone Detection Kit (Vet.) [Vet Chroma Progesterone]
|
N/A
|
N/A
|
N/A
|
Cartridge x 10's + Detection Buffer Tube x 10's + Capillary Cap x 10's+ Lot Chip x 1's
|
Veterinary Detection Kit (IVD) [Fluorescence Immunoassay (FIA)]
|
Boditech Med Inc.
|
Korea
|
N/A
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.) (Correction)
|
08 May 2025
|
08 January 2027
|
| View |
-
|
VR-MD0150
|
N/A
|
Canine Parvo Virus (CPV) + Canine Coronavirus
(CCV)+ Giardia Antigen Detection Kit (Vet.)
[Vet Chroma Canine 3D]
|
N/A
|
N/A
|
N/A
|
Cartridge x 10's + Detection Buffer Tube x 10's + Dropping Cap x 10's+ Lot Chip x 1's
|
Veterinary Detection Kit (IVD) [Fluorescence Immunoassay (FIA)]
|
Boditech Med Inc.
|
Korea
|
N/A
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.) (Correction)
|
08 May 2025
|
08 January 2027
|
| View |
-
|
VR-MD0151
|
Feline Pancreatic Lipase Detection Kit (Vet.)
[Vet Chroma fPL]
|
Vet Chroma™ Fpl
|
None
|
None
|
None
|
Cartridge x 10's+ Detection Buffer Tube x 10's Capillary Cap x 10's + Lot Chip x 1's
|
Veterinary Detection Kit (IVD) [Fluorescence Immunoassay (FIA)]
|
Boditech Med Inc.
|
Korea
|
N/A
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.) (Correction)
|
08 May 2025
|
08 January 2027
|
| View |
-
|
VR-MD0152
|
N/A
|
Canine Pancreatic Lipase Detection Kit (Vet.)
[Vet Chroma cPL]
|
N/A
|
N/A
|
N/A
|
Cartridge x 10's + Detection Buffer Tube x 10's + Capillary Cap x 10's+ Lot Chip x 1's
|
Veterinary Detection Kit (IVD) [Fluorescence Immunoassay (FIA)]
|
Boditech Med Inc.
|
Korea
|
N/A
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.) (Correction)
|
08 May 2025
|
08 January 2027
|
| View |
-
|
VR-MD0153
|
N/A
|
Canine N-Terminal Pro-B Type Natriuretic Peptide (NP) Detection Kit (Vet.)
[Vet Chroma CNT-proBNP]
|
N/A
|
N/A
|
N/A
|
Cartridge x 10's+ Granular Tube x 10's + Diluent x 1's Lot Chip x 1's
|
Veterinary Detection Kit (IVD) [Fluorescence Immunoassay (FIA)]
|
Boditech Med Inc.
|
Korea
|
N/A
|
Nordep Philmed Inc.
|
Nordep Philmed Inc.
|
Initial (Vet.) (Correction)
|
08 May 2025
|
08 January 2027
|
| View |
-
|
VR-MD0156
|
Avian Encephalomyelitis Virus (AEV) Antibody Detection Kit
(Vet.)
|
None
|
N/A
|
Diagnostic Kit/Reagent
|
Over-the-Counter (OTC)
|
Coated Microplate x 5's + Positive Control 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 Microplate x 10's + Positive Control 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 6'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 Medical Device (IVD)
[Enzyme-Linked Immunosorbent Assay (ELISA)]
|
Innovative Diagnostics
|
France
|
N/A
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial
|
17 February 2025
|
17 February 2027
|
| View |
-
|
VR-MD0161
|
Avian Influenza A Virus Polymerase Chain Reaction (PCR) Test Kit (Vet.)
|
None
|
N/A
|
Diagnostic Reagent/Kit
|
Over-the-Counter (OTC)
|
Positive Amplification Control in vial with Blue Cap x 100 μL + Amplification Reaction Mix in vial with White Cap x 400 μL; and (Box of 2's) Positive Amplification Control in vial with Blue Cap x 100 μL + Amplification Reaction Mix in vial with White Cap x 400 μL (Box of 2's)
|
Veterinary Diagnostic Kit (IVD)
[Polymerase Chain Reaction (PCR)]
|
Innovative Diagnostics SARL
|
France
|
N/A
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
05 March 2025
|
05 March 2027
|
| View |
-
|
VR-MD0162
|
None
|
African Swine Fever (ASF) Virus Antibody Detection Kit (Vet.)
|
N/A
|
N/A
|
N/A
|
Test Plate x 5's+ Positive Control x 600 μL + Negative Control x 600 μL + Dilution Buffer x 150 mL + Conjugate x 60 mL + Chromogen (TMB) Substrate x 60 mL + Stop Solution x 60 mL + Washing Fluid (20X) x 60 mL (Box of 2's)+ Plate Sealers x 10's
|
Veterinary Diagnostic Kit (IVD)
[Enzyme-Linked Immunosorbent Assay]
|
Prionics Lelystad B. V.
|
Netherlands
|
Life Technologies Holdings Pte. Ltd.
|
Infinnomed Enterprise
|
Infinnomed Enterprise
|
Initial (Vet.)
|
14 May 2025
|
14 May 2030
|
| View |
-
|
VR-MD0163
|
N/A
|
Canine Parvovirus (CPV) + Canine Coronavirus (CCV) + Giardia lamblia Antigen Test Kit (Vet.) [VetDiagnostix Canine Parvo Virus Corona Virus. Giardia lamblia CPV CCV GIA Test Kit]
|
None
|
None
|
Prescription Drug (RX)
|
Cassette Test Device in Aluminum Pouch x 1's (Box of 10's) + Disposable Droppers + Assay Buffer x 10's Swab Stick x 10's
|
Veterinary Diagnostic Kit (IVD)
|
Hangzhou Evegen Biotech Co., Ltd.
|
China
|
N/A
|
Vetdiagnostix Corp.
|
Vetdiagnostix Corp.
|
Initial (Vet.)
|
21 May 2025
|
21 May 2027
|