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The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A11-060
In Commercial Distribution
- B090A110601 ()
- B090A110600 ()
- B090A110602 ()
- Catheter Working Length: 60 Centimeter
- Catheter Gauge: 11 French
A11-060
- General-purpose syringe, single-use
- Thrombectomy suction catheter
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
5X-GW
In Commercial Distribution
- B0905XGW1 ()
- B0905XGW0 ()
- B0905XGW2 ()
5X-GW
- Torque manipulation device
ASPIRE Mechanical Aspirators for aspiration of fluids from the body anywhere a syringe is used.
ZIEN MEDICAL TECHNOLOGIES, INC.
30-ASP
In Commercial Distribution
- B09030ASP0 ()
- B09030ASP1 ()
- B09030ASP2 ()
30-ASP
- General-purpose syringe, single-use
Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.
BIO-MED DIAGNOSTICS, INC.
2483
In Commercial Distribution
- B08824834 ()
- B08824830 ()
- B08824832 ()
22-483-001
- Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
BIO-MED DIAGNOSTICS, INC.
2063
In Commercial Distribution
- B08820630 ()
- B08820634 ()
- B08820632 ()
22-063-000
- Multiple dermatophyte species culture isolate identification IVD, kit
Saline Solution (0.85%) is a saline solution for viral specimens.
BIO-MED DIAGNOSTICS, INC.
1612
In Commercial Distribution
- B08816120 ()
- B08816121 ()
- B08816122 ()
11-612-001
- Saline suspension medium/diluent IVD
The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans.
Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
BIO-MED DIAGNOSTICS, INC.
1602
In Commercial Distribution
- B08816026 ()
- B08816020 ()
- B08816021 ()
11-602-001
- Viral transport medium IVD
InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.
BIO-MED DIAGNOSTICS, INC.
1593
In Commercial Distribution
- B08815934 ()
- B08815930 ()
- B08815932 ()
21-593-001
- Multiple dermatophyte species culture isolate identification IVD, kit
Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds.
BIO-MED DIAGNOSTICS, INC.
1503
In Commercial Distribution
- B08815034 ()
- B08815030 ()
- B08815032 ()
21-503-001
- Basic/simple nutrient agar culture medium IVD
A medium devised for selection of non-typhi Salmonella from samples contaminated with fecal matter. Growth of other organisms is inhibited and Salmonella can be differentiated from other organisms by colony color.
BIO-MED DIAGNOSTICS, INC.
1493
In Commercial Distribution
- B08814934 ()
- B08814930 ()
- B08814932 ()
21-493-001
- Salmonella/Shigella species agar culture medium IVD