FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptima®
DI: 15420045512108
·
Model: KIT, MGEN, CONTROLS, AS, IVD
·
HOLOGIC LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aptima®
- Primary DI
- 15420045512108
- Version / Model
- KIT, MGEN, CONTROLS, AS, IVD
- Catalog Number
- PRD-04940
- Company Name
- HOLOGIC LTD.
- Labeler DUNS
- 230782021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-25
- Public Version
- 1
- Public Version Date
- 2024-07-03
- Public Version Status
- New
- Public Device Record Key
- a5a886d0-4450-4e2e-8944-b8998da04181
Device Description
The Mycoplasma genitalium in vitro transcript (IVT) controls are controls intended to be used with molecular assays that detect rRNA from Mycoplasma genitalium.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47323 | Mycoplasma genitalium 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 genitalium bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045512108 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius