FDA Registration
Active
🇺🇸 United States
MERCEDES MEDICAL LLC
Reg #: 1063851
·
FEI: 1000442352
·
Expires 2026
Products
84
Proprietary Names
83
Establishment Types
1
Classifications
84
Registration Details
- Registration Name
- MERCEDES MEDICAL LLC
- Registration Number
- 1063851
- FEI Number
- 1000442352
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12210 Rangeland Parkway
- City
- Lakewood Ranch
- State
- FL
- ZIP
- 34211
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001935
Owner / Operator
- Firm Name
- MERCEDES MEDICAL LLC
- Operator Number
- 9033351
- Address
- 12210 Rangeland Parkway, --
- City
- Lakewood Ranch
- State
- FL
- Postal Code
- 34211
- Country
- US
- Correspondent
- Misty - McWhorter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2024-11-01 |
| Cytocentrifuge | IFB | Class 1 | Pathology | No | 2025-09-17 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2017-12-15 |
| Stainer, Tissue, Automated | KEY | Class 1 | Pathology | No | 2019-12-10 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2024-01-08 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2024-01-08 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2024-01-08 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2024-03-13 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2024-03-13 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2019-02-11 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2024-01-08 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2024-01-08 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2019-07-25 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2022-05-03 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-03-30 |
| Device For Sealing Microsections | KIM | Class 1 | Pathology | No | 2025-09-17 |
| Fixative, Formalin-Containing | LDY | Class 1 | Pathology | No | 2019-02-11 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2005-05-26 |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2024-11-01 |
| Fixative, Alcohol Containing | LDZ | Class 1 | Pathology | No | 2019-02-11 |
| Ovens, Paraffin | IDR | Class 1 | Pathology | No | 2022-07-18 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2005-05-26 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-12-12 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-12-12 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-12-12 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2019-12-10 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2017-12-27 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2024-11-01 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2024-11-01 |
| Tube, Tissue Culture | KJG | Class 1 | Pathology | No | 2017-08-30 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2017-12-29 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2005-05-26 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2021-03-11 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2019-02-11 |
| Table, Slide Warming | IEG | Class 1 | Pathology | No | 2022-03-31 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2023-11-13 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-11-13 |
| Formulations, Paraffin, All | KEO | Class 1 | Pathology | No | 2023-12-12 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2018-09-26 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2024-11-01 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2024-01-08 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2025-05-12 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-09-19 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2025-05-12 |
| Mercuric Thiocyanate, Colorimetry, Chloride | CHJ | Class 2 | Clinical Chemistry | No | 2025-05-12 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2024-11-01 |
| Quality Control Slides | LJG | Class 1 | Microbiology | No | 2022-03-31 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2021-03-09 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2004-06-16 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-30 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | MXT | Class 1 | Pathology | No | 2018-02-16 |
| Slide Stainer, Immersion Type | KIO | Class 1 | Pathology | No | 2005-07-14 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2005-05-26 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2018-02-16 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2005-07-14 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2024-01-08 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2021-01-07 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2024-11-01 |
| Agent, Clearing | KEM | Class 1 | Pathology | No | 2005-07-14 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2008-01-28 |
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 2005-05-26 |
| Microtome, Freezing Attachment | IDN | Class 1 | Pathology | No | 2021-05-28 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2019-12-10 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2025-05-12 |
| Pipette, Pasteur | GJW | Class 1 | Hematology | No | 2005-05-26 |
| Bath, Flotation, Tissue | IDY | Class 1 | Pathology | No | 2021-10-25 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2024-11-01 |
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2018-01-08 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-03-30 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2018-01-08 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2025-05-12 |
| Microtome, Sliding | KFL | Class 1 | Pathology | No | 2021-05-28 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-11-27 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2023-11-27 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2024-01-08 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2024-11-01 |
Proprietary Names
Radioimmunoassay, testosterones and dihydrotestosterone
Galileo Series 2
Total T4
Biuret (colorimetric), Total Protein
Butterfly Needle
Ottix Plus; Access Wash Buffer II
Photometric Method, Iron (non-heme)
TSH
Urine Transfer Straw
BluWing Advanced Safety Butterfly 21g/23g/25g
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Safe Capsule; Sicura
Lab Equipment
Radioimmunoassay (two-site solid phase), ferritin
GreenFix
HIHG Capacity Section Dryer
Tanner
Polymer Patient
Cassette
Pipette Tip 1-200uL
System, Test, Vitamin D / Calibrator, Secondary
Culture Tube,13x100mm, 7mL, 250/BG
Tube, False Bottom, 5mL, PP, 1000/CS
Test Tube, 12x75mm, 5mL, 1000/BG
Test Tube, 13x100mm, 8mL PS, 1000/BG
Tube Screw Cap, False Bottom, White, 500
Test Tube, 12x75mm, 5mL, PP, 1000/BG
Transport Tube, 10mL, PP, White, 100/BG
Test Tube, 13x75mm, 5mL, PP, 1000/BG
Test Tube, 13x75mm, 5mL, PS, 1000/BG
Transport Tube, 10mL, PP White, 100/BG
Culture Tube,12x75mm, 5mL, 250/BG
Tanner Scientific Single Urine Specimen Collection Kit
Cristallo
Oral Swab, Nasopharyngeal Swab
high profile blade holder; low profile blade holder
SLEE SlideTec heat; SLEE Slidetec Water; SLEE Slidetec Water/Heat
AllTest Fentanyl Urine Test Cassette (Home Test)
BluTouch Nitrile Glove
Safety Multi-Drawing Needle with/without holder
Parafin56
Parafin58
Parafin53
Biopsy Bags
Lipase hydrolysis/glycerol kinase enzyme, triglycerides
Calibrator, Secondary / Ldl & Vldl Precipitationi, Cholesterol Via Esterase-Oxidase, Hdl
Needle, hypodermic, single lumen; Syringe, piston; blood collection
Single (Specified) Analyte Controls (Assayed And Unassayed)
Mercuric Thiocyanate, Colorimetry, Chloride
Urease and glutamic dehydrogenase, urea nitrogen
Printec Autoloa
Surgical Apparel
Cooling Plate
Manual Staining Set 12 Reservoirs, 450 ml; Tiziano
None
Tissue Processor
Donatello Series 2
BluWing Advanced
Starfrost; Tanner Scientific; Tanner Tape
Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Citoswab Collection and Transport Kit
NADY Oxidation/Nad Reduction, ALT/SGPT
Transition Reagent for Cristallo
Cyto Brush
10% NBF
Freezing Attachment
Tissue Culture Dish
Alkaline Picrate, Colorimetry, Creatinine
Pipette
Aquatec
Hexokinase, Glucose
Polymer Patient Examination Glove
BluWing Safety Blood Collection Set
Paraffin Dispenser
Tube, vials, systems, serum, separators, blood colleciton
UCP
Heagen
Cryostat
Enzymatic Esterase--Oxidase, Cholesterol
ClearRapids
Bromcresol Green Dye-Binding, Albumin
VacuFlow
Safety Blood Collection Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198