FDA Registration
Active
🇺🇸 United States
GLOBE SCIENTIFIC, LLC
Reg #: 2244900
·
FEI: 2244900
·
Expires 2026
Products
41
Proprietary Names
27
Establishment Types
2
Classifications
41
Registration Details
- Registration Name
- GLOBE SCIENTIFIC, LLC
- Registration Number
- 2244900
- FEI Number
- 2244900
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 400 CORPORATE DRIVE
- City
- Mahwah
- State
- NJ
- ZIP
- 07430
- Country
- US
Owner / Operator
- Firm Name
- GLOBE SCIENTIFIC, INC.
- Operator Number
- 2244900
- Address
- 400 CORPORATE DRIVE, --
- City
- Mahwah
- State
- NJ
- Postal Code
- 07430
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pipette, Diluting | GGY | Class 1 | Hematology | No | 2011-03-10 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2011-03-10 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2012-02-15 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2019-03-12 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2003-02-12 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2002-09-11 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2015-12-02 |
| Formaldehyde (Formalin, Formol) | IGG | Class 1 | Pathology | No | 2011-03-10 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2005-09-21 |
| Unit, Drying | JRJ | Class 1 | Clinical Chemistry | No | 2011-03-10 |
| Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | KDW | Class 1 | Pathology | No | 2011-03-10 |
| Micro Mixer | JRB | Class 1 | Clinical Chemistry | No | 2011-09-15 |
| Solution, Decalcifier, Acid Containing | KDX | Class 1 | Pathology | No | 2011-03-10 |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | Class 1 | Clinical Chemistry | No | 2002-09-11 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2003-02-12 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2011-03-10 |
| Shaker/Stirrer | JRQ | Class 1 | Clinical Chemistry | No | 2011-03-10 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2011-03-10 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2020-03-24 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2019-08-29 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2019-03-12 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2003-02-12 |
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 2011-03-10 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2020-01-24 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-03-19 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2019-07-11 |
| Pipette, Pasteur | GJW | Class 1 | Hematology | No | 2003-02-12 |
| Mixer, Blood Tube | GLE | Class 1 | Clinical Chemistry | No | 2011-09-15 |
| Tube, Tissue Culture | KJG | Class 1 | Pathology | No | 2011-03-10 |
| Centrifuge, Hematocrit | GKG | Class 2 | Hematology | No | 2019-07-11 |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | Class 1 | Pathology | No | 2011-03-10 |
| Pipette, Quantitative, Hematology | GJG | Class 1 | Hematology | No | 2011-03-10 |
| Tube, Sedimentation Rate | GHC | Class 1 | Hematology | No | 2003-02-12 |
| Test, Erythrocyte Sedimentation Rate | JPH | Class 1 | Hematology | No | 2011-03-10 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-09-23 |
| Hematocrit, Tube, Rack, Sealer, Holder | GHY | Class 2 | Hematology | No | 2019-03-12 |
| Fixative, Formalin-Containing | LDY | Class 1 | Pathology | No | 2003-02-12 |
| Blender/Mixer | JRO | Class 1 | Clinical Chemistry | No | 2011-09-15 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2003-02-12 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2019-03-12 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2008-06-03 |
Proprietary Names
Globe Brand
Container, Specimen
SLIDES
MICROSCOPE~PATHOLOGY
Pap-test Cervical Spatula
Cervical Scraper
LABORATORY DISPOSABLES
Cuvettes
Sample Cups
SPECIMEN~GENERAL HOSPITAL
Transfer Syringe
Inoculation Loops, Microbiology
TISSUE~PATHOLOGY
CASSETTES
Absorbent Tipped Applicator
PASTEUR~HEMATOLOGY
PIPETTE
Hematocrit Centrifuges
SEDIMENTATION RATE~HEMATOLOGY
Sedi-Rate
shield
Capillary Tube Sealant
FORMALIN-CONTAINING~PATHOLOGY
FIXATIVE
MICRO PIPETTE~CLINICAL CHEMISTRY
Container, Non-Sterile
Microhematocrit tube
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device