FDA UDI
In Commercial Distribution
🇺🇸 United States
Northeast Laboratory Services
DI: 00810144911243
·
Model: 1
·
Northeast Laboratory Services, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Northeast Laboratory Services
- Primary DI
- 00810144911243
- Version / Model
- 1
- Catalog Number
- X1265
- Company Name
- Northeast Laboratory Services, Inc.
- Labeler DUNS
- 071749709
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-21
- Public Version
- 1
- Public Version Date
- 2023-09-29
- Public Version Status
- New
- Public Device Record Key
- 55c427d8-81a7-43fa-9db3-34b589a4c05c
Device Description
Oxidase Reagent
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38062 | Oxidase production microbial reagent IVD | A substance or reactant, which may be impregnated on a strip or disc, intended to be used in microbial testing to detect the enzyme oxidase, produced by a microorganism isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810144911243 | GS1 |