FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693168984
·
Model: Acid Fast Bacillus Stain Kit (Green Secondary Stain)
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693168984
- Version / Model
- Acid Fast Bacillus Stain Kit (Green Secondary Stain)
- Catalog Number
- 87015
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-09
- Public Version
- 1
- Public Version Date
- 2024-08-19
- Public Version Status
- New
- Public Device Record Key
- b137ab19-153f-4fc1-a2bb-8978552f5124
Device Description
The Acid Fast Bacillus Stain Kit (87016) and components are for use as a kit in special stain techniques to detect acid fast bacteria. A waxy, lipid-rich cell wall surrounds the acid fast bacterium. This cell wall absorbs carbol fuchsin but is resistant to decoloration with acid alcohol. Bacteria that do not have a lipid-rich cell wall easily decolorize leaving the acid fast bacillus. Loeffler Methylene Blue Stain Solution provides a light blue counterstain to provide contrast for surrounding tissue elements from the brick red acid fast bacillus.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JTS | Stains, Microbiologic | 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 |
|---|---|---|---|---|---|---|
| Primary | 00673693168984 | GS1 |