FDA Registration
Active
🇺🇸 United States
SLMP LLC d.b.a. StatLab Medical Products
Reg #: 1640981
·
FEI: 1640981
·
Expires 2026
Products
47
Proprietary Names
120
Establishment Types
4
Classifications
47
Registration Details
- Registration Name
- SLMP LLC d.b.a. StatLab Medical Products
- Registration Number
- 1640981
- FEI Number
- 1640981
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2090 Commerce Drive
- City
- McKinney
- State
- TX
- ZIP
- 75069
- Country
- US
Owner / Operator
- Firm Name
- SLMP LLC (STATLAB MEDICAL PRODUCTS)
- Operator Number
- 10030272
- Address
- 2090 Commerce Dr.
- City
- McKinney
- State
- TX
- Postal Code
- 75069
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Biebrich Scarlet | ICN | Class 1 | Hematology | No | 2014-12-23 |
| Fluid, Bouin'S | IGN | Class 1 | Pathology | No | 2009-10-13 |
| Gold Chloride | HYH | Class 1 | Hematology | No | 2014-12-23 |
| Fast Green | HYC | Class 1 | Hematology | No | 2014-12-23 |
| Methylene Blue, Tissue Stain | KFC | Class 1 | Hematology | No | 2014-12-23 |
| Stains, Chemical Solution | LED | Class 1 | Hematology | No | 2013-12-26 |
| Orange G | HZH | Class 1 | Hematology | No | 2013-12-26 |
| Polyethylene Glycol Preservative | IFL | Class 1 | Pathology | No | 2013-12-26 |
| Agent, Clearing | KEM | Class 1 | Pathology | No | 2009-10-13 |
| Hematoxylin Weigert'S | HYO | Class 1 | Hematology | No | 2014-12-23 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2009-10-15 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 2016-04-17 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2018-04-24 |
| Iron Stains | GGH | Class 1 | Hematology | No | 2014-12-23 |
| Stains, Dye Solution | LEE | Class 1 | Hematology | No | 2013-12-26 |
| Toluidine Blue | IAB | Class 1 | Hematology | No | 2014-12-23 |
| Formulations, Paraffin, All | KEO | Class 1 | Pathology | No | 2014-12-23 |
| Aniline Blue | KFD | Class 1 | Hematology | No | 2014-12-23 |
| Preservative, Cytological | LEA | Class 1 | Pathology | No | 2009-10-15 |
| Silver Nitrate | HZX | Class 1 | Hematology | No | 2014-12-23 |
| Van Gieson'S Stain | IAC | Class 1 | Hematology | No | 2014-12-23 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2014-12-19 |
| Media, Mounting, Water Soluble | KEQ | Class 1 | Pathology | No | 2009-10-13 |
| Formaldehyde (Formalin, Formol) | IGG | Class 1 | Pathology | No | 2011-12-15 |
| Fixative, Alcohol Containing | LDZ | Class 1 | Pathology | No | 2009-10-15 |
| Fixative, Acid Containing | LDW | Class 1 | Pathology | No | 2011-12-15 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2009-10-13 |
| Fixative, Formalin-Containing | LDY | Class 1 | Pathology | No | 2009-10-13 |
| Hematoxylin Harris'S | HYK | Class 1 | Hematology | No | 2009-10-13 |
| Stains, Hematology | KQC | Class 1 | Hematology | No | 2013-12-26 |
| Eosin Y | HYB | Class 1 | Hematology | No | 2009-10-13 |
| Giemsa Stain | HYF | Class 1 | Hematology | No | 2014-12-23 |
| Nuclear Fast Red | HZF | Class 1 | Hematology | No | 2014-12-23 |
| Solution, Formalin-Alcohol-Acetic Acid | IGF | Class 1 | Pathology | No | 2011-12-15 |
| Light Green | HYS | Class 1 | Hematology | No | 2014-12-23 |
| Hematoxylin | HYJ | Class 1 | Hematology | No | 2009-10-13 |
| Alcian Blue | IDA | Class 1 | Hematology | No | 2014-12-23 |
| Solution, Decalcifier, Acid Containing | KDX | Class 1 | Pathology | No | 2011-12-15 |
| Reagent, Schiff | HZT | Class 1 | Hematology | No | 2013-12-26 |
| Stain, Papanicolau | HZJ | Class 1 | Hematology | No | 2009-10-13 |
| Carbol Fuchsin | ICL | Class 1 | Hematology | No | 2014-12-23 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2011-12-15 |
| Congo Red | ICH | Class 1 | Hematology | No | 2014-12-23 |
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 2009-10-13 |
| Safranin | HZS | Class 1 | Hematology | No | 2014-12-23 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2009-10-13 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2016-04-17 |
Proprietary Names
Bouin's Solution
StatLab Bouin Prefill
GOLD CHLORIDE
Fast Green Counterstain
Methylene Blue Stain
High Def 1% Acid Rinse
Reserve Bluing
Vintage Bluing
Select Bluing
Focus 0.5% Acid Alcohol
High-Def
Select Acid Rinse
Focus 1% Acid Alcohol
OG-6
Saccomanno Fluid
StatLab Saccomanno Prefill
Plus Alcohol 100%
Isopropyl Alcohol
Methanol
RGA 95%
Citra Clear
Isopropyl Alcohol 70%
Xylene
Plus Alcohol 95%
IsoClear
XS-3
RGA 50% w/Type 1 Water
RGA 70% w/ Type 1 Water
RGA 80%
RGA 100%
WEIGERT'S HEMATOXYLIN
StatLab Reagent
CYTOLOID Mucolytic Reagent
StatLab pH Buffer
StatLab Quantum Slide Stainer
Iron Hematoxylin, Solution
Margin Marker
Toluidine Blue Stock Solution
Parapro
ANILINE BLUE STAIN
StatPrep Preserve
StatPrep Cell Solution
PrepCyte Preserve GYN, Prepcyte NON GYN
Van Gieson's Stain
StatLab
Submount
Acrymount
37% Formaldehyde
StatLab GTF Prefill
Prostate Biopsy Kit
StatLab ANBF Prefill
CytoVial
StatLab AZF Prefill
StatLab Biopsy Kit
Optic Mount
Acrymount PLUS
StatLab Carson Millonig Prefill
10% Modified Carson/Millonig
Buffered Zinc Formalin
StatLab BFZ Prefill
StatLab Hollandes Prefill
StatLab Michels Fixative Prefill
B-Fixative
Zinc Formalin Concentrate
StatLab BFix Prefill
Formalin 10% Non-Buffered
Formalin 20% NBF
StatFix
Harris Hematoxylin
Hema-Diff # 1 Fixative
Hema-Diff #3 Thiazine
Hema-Diff #2 Xanthene
Eosin Y Alcoholic
Eosin with Phloxine B
Vintage Eosin
Reserve Eosin Multichrome
Treosin
Select Eosin
Giemsa Stain
Nuclear Fast Red
Lymph ID
Light Green Counterstain
Gill 3
Gill 2
Vintage Hematoxylin
Reserve Hematoxylin
Gill 1
Vintage Plus Hematoxylin
Select Hematoxylin
Stain Kit Mucicarmine
Hematoxylin Solution (5%)
Hematoxylin, Mayer's
Alcian Blue Solution
EDF
RDF
Nail Prep
Periodic Acid
Schiff's Reagent
Modified EA 50
EA-50
Classical EA 50
Reserve CytoDx
EA-65
SLIDES, MICROSCOPE
StatClick
StatLab NBF Prefill
Formalin NBF 10%
Safranin O Stain
Unisette Routine Smartload
Slimsette Biopsy Smartload
Histosette II Biopsy Smartload
Sleeved Biopsy II Cassette
Micromesh Biopsy Smartload
Microsette I Biopsy Smartload
Unisette Biopsy Smartload
Histosette II Routine Smartload
Sleeved Histosette II Cassette
Slimsette Routine Smartload
PathFlow cassettes
StatLab Immunohistochemistry Reagents and Kits
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198