| 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-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-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-MD0149
|
N/A
|
Progesterone Detection Kit (Vet.) [Vet Chroma Progesterone]
|
N/A
|
Aqueous
|
Prescription Drug (RX)
|
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.)
|
08 January 2025
|
08 January 2027
|
| 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-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-MD0150
|
N/A
|
Canine Parvo Virus (CPV) + Canine Coronavirus
(CCV)+ Giardia Antigen Detection Kit (Vet.)
[Vet Chroma Canine 3D]
|
N/A
|
Aqueous
|
Prescription Drug (RX)
|
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.)
|
08 January 2025
|
08 January 2027
|
| View |
-
|
VR-MD0151
|
Feline Pancreatic Lipase Detection Kit (Vet.)
[Vet Chroma fPL]
|
Vet Chroma™ Fpl
|
None
|
Aqueous
|
Prescription Drug (RX)
|
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.)
|
08 January 2025
|
08 January 2027
|
| View |
-
|
VR-MD0152
|
N/A
|
Canine Pancreatic Lipase Detection Kit (Vet.)
[Vet Chroma cPL]
|
N/A
|
Aqueous
|
Prescription Drug (RX)
|
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.)
|
08 January 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
|
Freeze-Dried
|
Prescription Drug (RX)
|
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.)
|
08 January 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-MD0157
|
Classical Swine Fever (CSF) Virus Antibody Detection Kit (Vet.)
|
None
|
N/A
|
Diagnostic Reagent/Kit
|
Over-the-Counter (OTC)
|
Coated Microplate x 5's + Positive Control 2 mL + Negative Control x 2 mL + Dilution Buffer 8 x 60 mL + Conjugate 10x x 6 mL + Dilution Buffer 12 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 2 mL (Box of 2's) + Negative Control x 2 mL (Box of 2's) + Dilution Buffer 8 x 60 mL + Conjugate 10x x 6 mL (Box of 2's) + Dilution Buffer 12 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]
|
Innovative Diagnostics
|
France
|
N/A
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial
|
21 February 2025
|
21 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-MD018
|
African Swine Fever (ASF) Virus Polymerase Chain Reaction (PCR) Test Kit (Vet.)
|
None
|
N/A
|
Diagnostic Reagent/Kit
|
Over-the-Counter (OTC)
|
Possitive Amplification Conrol in vial with Blue Cap x 100 uL + Non-Target Possiive Control in vial with Green Cap x 2 mL X Amplification Reaction Mix in vial with White Cap x 400 uL : and Positive Amplification Control in vial with Blue Cap x 100 uL + Non-Target Positive Control x 2 mL x + Amplification Reaction Mix in vial with White Cap x 400 uL + (Box of 2's)
|
Veterinary Diagnostic Kit (IVD)
|
Innovative Diagnostics SARL
|
France
|
N/A
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial (Vet.)
|
20 December 2024
|
20 December 2026
|
| View |
|
VR-NM0001
|
Grooming Soap
|
Bayopet Clean n' Shine Soap
(Jojoba Oil with Apple Scent)
|
NA
|
Dog Soap
|
Over-the-Counter (OTC)
|
20 g and 90 g Soap (Box of 1's)
|
-
|
Marklene Fabricate Corporation
|
Philippines
|
Elanco Philippines Inc
|
N/A
|
N/A
|
-
|
20 May 2021
|
20 May 2026
|
| View |
|
VR-NM0002
|
Grooming Shampoo
|
Bayopet Conditioning Shampoo (Jojoba Oil with Apple Scent)
|
NA
|
Dog Shampoo
|
Over-the-Counter (OTC)
|
HDPE Bottle x 20 mL and 275 mL
|
-
|
Marklene Fabricate Corporation
|
Philippines
|
Elanco Philippines Inc
|
N/A
|
N/A
|
-
|
20 May 2021
|
20 May 2026
|
| View |
|
VR-NM0003
|
Grooming Shampoo
|
Bayopet Moisturizing And Antiseptic Shampoo (Coconut Milk with Cucumber Scent)
|
N/A
|
Dog Shampoo
|
Over-the-Counter (OTC)
|
HDPE Bottle x 20 mL and 275 mL
|
-
|
Marklene Fabricate Corporation
|
Philippines
|
Elanco Philippines Inc
|
N/A
|
N/A
|
-
|
20 May 2021
|
20 May 2026
|
| View |
|
VR-NM0004
|
Grooming Shampoo
|
Bayopet Herbal Hair Grower Shampoo (Aloe Vera with Balsam Scent)
|
NA
|
Dog Shampoo
|
Over-the-Counter (OTC)
|
HDPE Bottle x 20 mL and 275 mL
|
-
|
Marklene Fabricate Corporation
|
Philippines
|
Elanco Philippines Inc
|
N/A
|
N/A
|
-
|
20 May 2021
|
20 May 2026
|
| View |
-
|
VR-MD0158
|
Bluetongue Virus (BTV) Antibody Detection Kit (Vet.)
|
None
|
N/A
|
Diagnostic Kit/Reagent
|
Over-the-Counter (OTC)
|
Coated Microplate x 5's+ Positive Control 1 mL (Box of 2's) + Negativo x 1 mL (Box of 2's) + Dilution Buffer 2 x 60 mL (Box of 2's)+ Conjugate 10x x 6 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 1 mL (Box of 3's) + Negative Control x 1 mL (Box of 3's) + Dilution Buffer 2 x 60 mL (Box of 4's)+ Conjugate 10x x 6 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-MD0159
|
Avian Infectious Laryngotracheitis (ILT) Virus Antibody
Detection Kit (Vet.)
|
None
|
N/A
|
Diagnostic Reagent/Kit
|
Over-the-Counter (OTC)
|
Coated Microplate x 2's + Positive Control x 3.5 mL + Negative Control x 3.5 mL + Dilution Buffer 14 x 60 mL + 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; Coated Microplate x 5's+ Positive Control 3.5 mL + Negative Control x 3.5+ 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
L+ Solution x 60 mL; and Coated Microplate x 10's + Positive Control 3.5 mL (Box of 2's) + Negative Control x 3.5 (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 (Elisa)
|
Innovative Diagnostics
|
France
|
N/A
|
Lifeline Diagnostics Supplies, Inc.
|
Lifeline Diagnostics Supplies, Inc.
|
Initial
|
17 February 2025
|
17 February 2027
|