| View |
|
VR-MD0031
|
Avian Encephalomyelitis (AE) Virus Antibody Test Kit
(Vet.)
|
IDEXX AE Ab Test
|
None
|
None
|
None
|
Each box contains:
AE 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.) A
|
29 June 2022
|
29 June 2027
|
| View |
|
VR-MD0032
|
Avian Reovirus (REO) Antibody Test Kit (Vet.)
|
IDEXX REO Ab Test
|
None
|
None
|
None
|
Each box contains:
REO 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.
|
USA
|
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal
|
29 June 2022
|
29 June 2027
|
| View |
|
VR-MD0033
|
Newcastle Disease (ND) Virus Antibody Test Kit
(Vet.)
|
IDEXX NDV Ab Test
|
None
|
None
|
None
|
Each box contains:
NDV 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
|
-
|
IDEXX Laboratories, Inc.
|
USA
|
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal
|
29 June 2022
|
29 June 2027
|
| View |
|
VR-MD0034
|
Mycoplasmopsis synoviae (Ms) Antibody Test Kit
(Vet.)
|
IDEXX MS Ab Test :
|
None
|
None
|
None
|
Each box contains:
Ms 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.
|
USA
|
N/A
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal (Vet.)
|
30 June 2022
|
30 June 2027
|
| View |
|
VR-MD0035
|
IDEXX Herdcheck Pseudorabies Virus Gb Test
|
Idexx Herdcheck Pseudorabies Virus Gb Test
|
None
|
None
|
None
|
Each box contains:
PRV Antigen Coated Plates in Polymer Bag x 6's and 30's + Positive Control x 3 mL and 7 mL + Negative Control x 3 mL and 7 mL + Conjugate x 60 mL and 350 mL + Diluent x 120 mL and 300 mL + TMB Substrate x 60 mL and 315 mL + Stop Solution x 60 mL and 315 mL + Wash Concentrate x 235 mL and 480 mL in LDPE Bottles
|
Veterinary Medical Device (IVD) [Enzyme-linked Immunoassay (ELISA)]
|
IDEXX Laboratories AG
|
Switzerland
|
N/A
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal (Vet.)
|
30 June 2022
|
30 June 2027
|
| View |
|
VR-MD0036
|
Porcine Reproductive and Respiratory Syndrome
(PRRS) Virus Antibody Test Kit (Vet.)
|
IDEXX PRRS X3 Ab Test
|
None
|
None
|
None
|
Each box contains:
PRRSV Antigen Coated Plates in Polymer Bag x 2’s and 5's + Positive Control x 3 mL and 4 mL + Negative Control x 3 mL and 4 mL + Conjugate x 25 mL and 60 mL + Diluent x 50 mL and 120 mL + TMB Substrate x 20 mL and 60 mL + Stop Solution x 20 mL and 60 mL + Wash Concentrate x 125 mL and 235 mL in LDPE Bottles
|
-
|
IDEXX Laboratories AG
|
Switzerland
|
N/A
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal (Vet.)
|
30 June 2022
|
30 June 2027
|
| View |
|
VR-MD0037
|
Porcine Reproductive and Respiratory Syndrome (PRRS) Virus Antibody Test Kit (Vet.)
|
IDEXX PRRS of (Oral Fluid) Ab Test
|
None
|
None
|
None
|
Each box contains:
PRRSV Antigen Coated Plates in Polymer Bag x 5's + Positive Control x 4 mL + Negative Control x 4 mL + Conjugate x 60 mL + Diluent x 120 mL + TMB Substrate x 60 mL + Stop Solution x 60 mL + Wash Concentrate x 235 mL in LDPE Bottles
|
Veterinary Medical Device (IVD) [Enzyme-linked Immunoassay (ELISA)]
|
IDEXX Laboratories AG
|
Switzerland
|
N/A
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal (Vet.)
|
30 June 2022
|
30 June 2027
|
| View |
|
VR-MD0038
|
Infectious Bronchitis (IB) Virus Antibody Test Kit
|
CIVTEST Avi IBV
|
Not applicable
|
Not applicable
|
None
|
Each box contains:
IBV antigen coated plates in polymer bag 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 Solution x 125 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
|
|
Hipra Philippines, Inc.
|
Hipra Philippines, Inc.
|
Renewal (Vet.)
|
07 July 2022
|
07 July 2027
|
| View |
|
VR-MD0039
|
Infectious Bursal Disease (IBD) Virus Antibody Test Kit
|
CIVTEST Avi IBD
|
Not applicable
|
Not applicable
|
Not applicable
|
Each box contains:
IBDV antigen coated plates in polymer bag 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 Solution x 125 mL + Dilution Buffer x 125 mL + ABTS solution x 30 mL in HDPE bottles
|
-
|
Laboratorios Hipra, S.A
|
Spain
|
|
Hipra Philippines, Inc.
|
Hipra Philippines, Inc.
|
Renewal (Vet.)
|
07 July 2022
|
07 July 2027
|
| View |
|
VR-MD0040
|
African Swine Fever (ASF) Virus DNA Mix Test Kit (Vet.)
|
IDEXX RealPCR ASFV DNA Mix
|
None
|
None
|
None
|
Each box contains:
ASFV DNA Mix x 1 mL + DNA Master Mix x 1 mL + Positive Control x 0.5 mL + PCR Grade Water x 1 mL (2’s) in LDPE Vials
|
Veterinary Medical Device (IVD)
|
IDEXX Montpellier SAS
|
France
|
N/A
|
Metro Drug, Inc.
|
Metro Drug, Inc.
|
Renewal (Vet.)
|
05 July 2022
|
05 July 2027
|
| 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
|