FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00819398023856
·
Model: U192
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- N/A
- Primary DI
- 00819398023856
- Version / Model
- U192
- Catalog Number
- U192
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-06-05
- Public Version
- 1
- Public Version Date
- 2020-06-15
- Public Version Status
- New
- Public Device Record Key
- ac62b3ab-a9ff-4e36-9130-4c375dbf4f1a
Device Description
Phosphate Buffer, pH 6.8, 1 liter, polycarbonate bottle, order by the package of 10 Phosphate Buffer, 500ml for the preparation of specimens for AFB culture
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 |
|---|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42624 | Sputum liquefaction/decontamination reagent IVD | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the liquefaction, digestion, and/or decontamination of a sputum specimen suspected of containing microorganisms associated with respiratory disease (e.g., Streptococcus pneumoniae, Mycobacterium tuberculosis) in preparation for further processing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00819398023849 | GS1 | ||||
| Primary | 00819398023856 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius