FDA UDI
In Commercial Distribution
🇺🇸 United States
Alethia™ Mycoplasma Direct External Control Kit
DI: 00840733102103
·
Model: 479890
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alethia™ Mycoplasma Direct External Control Kit
- Primary DI
- 00840733102103
- Version / Model
- 479890
- Catalog Number
- 479890
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-08
- Public Version
- 1
- Public Version Date
- 2019-02-08
- Public Version Status
- New
- Public Device Record Key
- a272f516-33a8-4771-a8b4-5ce36a8face2
Device Description
The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.
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 |
|---|---|---|---|---|
| OZX | Mycoplasma Pneumoniae Dna Assay System | Microbiology | 866.3980 | 2 |
| OOI | Real Time Nucleic Acid Amplification System | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47327 | Mycoplasma pneumoniae nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Mycoplasma pneumoniae bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733102103 | GS1 |
Customer Contacts
- Phone
- 513-271-3700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160829 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius