FDA UDI
In Commercial Distribution
🇺🇸 United States
LanaGram™
DI: 00819398026772
·
Model: Z49
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
15
Basic Information
- Brand Name
- LanaGram™
- Primary DI
- 00819398026772
- Version / Model
- Z49
- Catalog Number
- Z49
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2020-06-16
- Public Version
- 1
- Public Version Date
- 2020-06-24
- Public Version Status
- New
- Public Device Record Key
- 0d302411-3c24-492d-8cce-2fae5994462e
Device Description
LanaGram™, rapid color test for bacterial gram reaction, 15 tests per package For organisms that are difficult to gram stain. Uses the aminopeptidase reaction. LanaGram™ confirms the gram stain reaction of gram-negative and gram-positive aerobic or facultatively anaerobic rods or coccobacilli. This test is not recommended for use with gram-positive cocci, microaerophilic or obligate anaerobic organisms.
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 |
|---|---|---|---|---|
| JSF | Culture Media, Single Biochemical Test | Microbiology | 866.2320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43733 | Gram stain IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in a Gram stain (also referred to as Brown and Benn or Brown-Hopps stain), that is used for the demonstration and differentiation of bacteria in biological/clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00819398026765 | GS1 | ||||
| Primary | 00819398026772 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius