FDA UDI
In Commercial Distribution
🇺🇸 United States
PREMIER Rotaclone
DI: 00840733101700
·
Model: 696004
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PREMIER Rotaclone
- Primary DI
- 00840733101700
- Version / Model
- 696004
- Catalog Number
- 696004
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 1
- Public Version Date
- 2020-09-09
- Public Version Status
- New
- Public Device Record Key
- 6353a76d-1a7d-4e9d-8faf-69dc2a0e62de
Device Description
Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | Microbiology | 866.3405 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50244 | Rotavirus antigen IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Rotavirus in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733101700 | GS1 |
Customer Contacts
- Phone
- 513-271-3700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K852969 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius