FDA Registration
Active
🇬🇧 United Kingdom
Streptococcal Grouping Kit
Reg #: 8010096
·
FEI: 3006224287
·
Expires 2025
Products
1
Proprietary Names
30
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OXOID, LTD.
- Registration Number
- 8010096
- FEI Number
- 3006224287
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- WADE RD.
- City
- BASINGSTOKE, HAMPSHIRE
- Country
- GB
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
US Agent
- Business Name
- Remel, Inc
- Contact Name
- Alycia Jayroe
- Address
- 12076 Santa Fe Trail
- City
- Lenexa
- State
- KS
- ZIP
- 66215
- Country
- US
- [email protected]
- Phone
- 913 9540078
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antisera, All Groups, Streptococcus Spp. | GTZ | Class 1 | Microbiology | No | 2002-02-27 |
Proprietary Names
Streptococcal Grouping Kit
Polyvalent Positive Control
Extraction Enzyme
Streptococcal Grouping Reagent C
DR0707G PathoDxtra Polyvalent Positive Control
DR0704G PATHODXTRA STREP GROUP D LATEX
DR0702G PATHODXTRA STREP GROUP B LATEX
DR0709M PathoDxtra Extraction Reagents
DR0589G Latex Grouping Reagent D
DR0700M PathoDxtra Strep Grouping Kit (60 tests)
DR0587G Latex Grouping Reagent B
DR0710M PATHODXTRA STREP GROUPING REAGENT SET
Streptococcal Grouping Reagent A
Streptococcal Grouping Reagent F
DR0705G PATHODXTRA STREP GROUP F LATEX
Streptococcal Grouping Reagent D
Streptococcal Grouping Reagent B
DR0590G Latex Grouping Reagent F
DR0591G Latex Grouping Reagent G
DR0500G Oxoid Reaction Cards
Strep Plus Extraction Reagent Kit
DR0703G PATHODXTRA STREP GROUP C LATEX
DR0701G PATHODXTRA STREP GROUP A LATEX
DR0586G Latex Grouping Reagent A
DR0588G Latex Grouping Reagent C
DR0720G PATHODXTRA DISPOSABLE CARDS
DrySpot Pneumo
Streptococcal Grouping Reagent G
Strep Plus Kit
DR0706G PATHODXTRA STREP GROUP G LATEX
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility