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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.
A7-060
In Commercial Distribution
- B090A70600 ()
- B090A70601 ()
- B090A70602 ()
- Catheter Working Length: 60 Centimeter
- Catheter Gauge: 7 French
A7-060
- Thrombectomy suction catheter
- General-purpose syringe, single-use
ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A6-055
In Commercial Distribution
- B090A60550 ()
- B090A60551 ()
- B090A60552 ()
A6-055
- General-purpose syringe, single-use
- Thrombectomy suction catheter
ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-135
In Commercial Distribution
- B090A51352 ()
- B090A51351 ()
- B090A51350 ()
A5-135
- General-purpose syringe, single-use
- Thrombectomy suction catheter
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
Highly selective medium for the isolation of Salmonella other than S. typhi from feces and other materials.
BIO-MED DIAGNOSTICS, INC.
1463
In Commercial Distribution
- B08814634 ()
- B08814630 ()
- B08814632 ()
21-463-001
- MLCB Salmonella species agar culture medium IVD