| View |
|
VR-MD0041
|
Mycoplasmoides gallisepticum (Mg) Antibody Test Kit
(Vet.)
|
IDEXX MG Ab Test
|
None
|
None
|
None
|
Each box contains:
Mg Antigen Coated Plates in Polymer Bag 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.)
|
05 July 2022
|
05 July 2027
|
| View |
|
VR-MD0042
|
Turkey Rhinotracheitis (TRT) Virus Antibody Test Kit
|
CIVTEST Avi TRT
|
N/A
|
N/A
|
None
|
Each box contains:
TRT antigen coated plates in eight well strips x 5's + Positive Control x 2.2 mL + Negative Control x 2.2 mL + Conjugate x 30 mL + Stop Solution x 30 mL + Wash Solutions (2) x 100 mL + Dilution Buffer x 125 mL + ABTS solution x 30 mL in HDPE bottles
|
Veterinary Medical Device (IVD)
Enzyme Linked Immunosorbent Assay (ELISA)
|
Laboratorios Hipra, S.A
|
Spain
|
N/A
|
Hipra Philippines, Inc.
|
Hipra Philippines, Inc.
|
Renewal [Vet.)
|
19 July 2022
|
19 July 2027
|
| View |
|
VR-MD0043
|
Egg Drop Syndrome (EDS-76) Virus Antibody Test Kit
|
CIVTEST AVI EDS
|
N/A
|
N/A
|
None
|
Each box contains:
EDS antigen coated plates in eight well strips x 5's +
+ Conjugate x 30 mL + Stop Solution x 30 mL + Wash Solutions (2) x 100 mL + Dilution Buffer x 125 mL + ABTS solution x 30 mL in HDPE Bottles
|
Veterinary Medical Device (IVD)
Enzyme Linked Immuno Sorbent Assay (ELISA)
|
Laboratorios Hipra, S.A
|
Spain
|
N/A
|
Hipra Philippines, Inc.
|
Hipra Philippines, Inc.
|
Renewal [Vet.)
|
19 July 2022
|
19 July 2027
|
| View |
|
VR-MD0044
|
Ehrlichia canis Antibody Test Kit
|
Vetlab
|
None
|
None
|
None
|
Each box contains:
Plastic containing E. canis antigen in a foil pouch x 10's, dilution buffer x l's, dropper x 10's in HDPE bottles
|
-
|
Shenzhen Zhenrui Biotech Co., Ltd
|
China
|
|
Healthwinds Medical Trading Corp.
|
Healthwinds Medical Trading Corp.
|
Renewal [Vet.)
|
27 July 2022
|
27 July 2027
|
| View |
|
VR-MD0045
|
Toxoplasma gondii Antibody Test Kit
|
Vetlab
|
None
|
None
|
None
|
Each box contains:
Plastic cassette containing Toxoplasma gondii antibody in a foil pouch x 10's, dropper x 10's
|
Veterinary Medical Device (IVD)
Immunochromatographic Assay (ICA)
|
Shenzhen Zhenrui Biotech Co., Ltd
|
China
|
|
Healthwinds Medical Trading Corp.
|
Healthwinds Medical Trading Corp.
|
Renewal Vet
|
28 July 2022
|
28 July 2027
|
| View |
|
VR-MD0046
|
Canine Heartworm (Dirofilaria immitis) Antigen Test
Kit
|
Vetlab
|
None
|
None
|
None
|
Each box contains:
Plastic cassette containing Canine Heartworm (Dirofilaria immitis) antigen in a foil pouch x 10's, dilution buffer x l's, dropper x 10's in HDPE bottles
|
Veterinary Medical Device (IVD)
Immunochromatographic Assay (ICA)
|
Shenzhen Zhenrui Biotech Co., Ltd
|
China
|
|
Healthwinds Medical Trading Corp.
|
Healthwinds Medical Trading Corp.
|
Renewal [Vet.)
|
27 July 2022
|
27 July 2027
|
| View |
|
VR-MD0047
|
Rapid Canine Distemper Virus (CDV) Antigen Test Kit
|
Vetlab Rapid CDV Ag Test Kit :
|
None
|
None
|
None
|
Each box contains:
Cassette test kit sealed in Aluminum Foil Bag with Dropper x l's (Box of 10's) + Dilution Buffer in PP Bottle with Blue Cap x 0.9 mL (Box of 10's) + Cotton Swab x 10's
|
Veterinary Medical Device (IVD)
[Immunochromatographic Assay]
|
Shenzhen Zhenrui Biotech Co., Ltd.
|
China
|
|
Healthwinds Medical Trading Corp
|
Healthwinds Medical Trading Corp
|
Initial [Vet]
|
31 August 2022
|
31 August 2027
|
| View |
|
VR-MD0048
|
Canine Parvovirus (CPV) Antigen Test Kit
|
Vetlab Rapid CPV Ag Test Kit
|
None
|
None
|
None
|
Each box contains:
Cassette test kit sealed in Aluminum Foil Bag with Dropper x l's (Box of 10's) + Dilution Buffer in PP Bottle with Pink Cap x 0.9 mL (Box of 10's) + Cotton Swab x 10's + Disposable Gloves x 4's
|
-
|
Shenzhen Zhenrui Biotech Co., Ltd.
|
China
|
|
Healthwinds Medical Trading Corp
|
Healthwinds Medical Trading Corp
|
Initial |Vet.]
|
31 August 2022
|
31 August 2027
|
| View |
|
VR-MD0049
|
Rapid Feline Coronavirus (FCV) Antigen Test Kit
|
Vetlab Rapid FCOV Ag Test Kit
|
None
|
None
|
None
|
Each box contains:
Cassette test kit sealed in Aluminum Foil Bag with Dropper xl's (Box of 10's) + Dilution Buffer in PP Bottle with Pink Cap x 0.9 mL (Box of 10's) + Cotton Swab x 10's + Disposable Gloves x 4's
|
-
|
Shenzhen Zhenrui Biotech Co., Ltd.
|
China
|
|
Healthwinds Medical Trading Corp
|
Healthwinds Medical Trading Corp
|
Initial (Vet.]
|
31 August 2022
|
31 August 2027
|
| View |
|
VR-MD0050
|
Bluetongue Virus Antibody Test Kit
|
VMRD Bluetongue
|
NA
|
NA
|
None
|
Each box contains:
Antigen coated plates in mylar pouches (Box of 2's and 5's) + Positive Control x 4 mL + Negative Control x 4 mL + Antibody-Peroxidase Conjugate x 16 mL + 50x Wash Solution Concentrate x 60 mL + Substrate Solution x 30 mL + Stop Solution x 30 mL
|
Veterinary Medical Device (IVD)
[Enzyme-Linked Immunosorbent Assay (ELISA)]
|
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-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
|