FDA UDI
In Commercial Distribution
🇺🇸 United States
Alpha-Tec Systems
DI: 00816085023571
·
Model: 0
·
Alpha-TEC Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
8
Basic Information
- Brand Name
- Alpha-Tec Systems
- Primary DI
- 00816085023571
- Version / Model
- 0
- Catalog Number
- 0003530C
- Company Name
- Alpha-TEC Systems, Inc.
- Labeler DUNS
- 103105524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2022-08-08
- Public Version
- 1
- Public Version Date
- 2022-08-16
- Public Version Status
- New
- Public Device Record Key
- 57696f8e-dde3-4ecf-80fe-c80aa7830b23
Device Description
Auramine O/Rhodamine B Stain 8x250ml
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| KJK | Auramine O | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43587 | Biological stain IVD | A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00816085023564 | GS1 | ||||
| Primary | 00816085023571 | GS1 |