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The Control Mechanical Aspirator is intended to aspirate fluids from the body.
ZIEN MEDICAL TECHNOLOGIES, INC.
30-ASP
In Commercial Distribution
- B09030ASP0 ()
- B09030ASP1 ()
- B09030ASP2 ()
30-ASP
- General-purpose syringe, single-use
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-S
In Commercial Distribution
- B0902P0130S1 ()
- B0902P0130S0 ()
- B0902P0130S2 ()
- Catheter Length: 130 Centimeter
- Catheter Gauge: 2 French
2P0-130-S
- Vascular microcatheter
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-B
In Commercial Distribution
- B0902P0130B1 ()
- B0902P0130B0 ()
- B0902P0130B2 ()
- Catheter Length: 130 Centimeter
- Catheter Gauge: 2 French
2P0-130-B
- Vascular microcatheter
A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
BIO-MED DIAGNOSTICS, INC.
1223
In Commercial Distribution
- B08812234 ()
- B08812230 ()
- B08812232 ()
21-223-001
- Chromogenic Salmonella species agar culture medium IVD
For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
BIO-MED DIAGNOSTICS, INC.
1103
In Commercial Distribution
- B08811034 ()
- B08811030 ()
- B08811032 ()
21-103-001
- Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid
Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution
- B08810310 ()
- B08810317 ()
- B08810313 ()
21-031-001
- Differential/selective broth culture medium IVD
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