FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptima®
DI: 15420045500242
·
Model: KIT, AC2 ASSAY FL, TIG, IVD-CE (302382)
·
Hologic, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aptima®
- Primary DI
- 15420045500242
- Version / Model
- KIT, AC2 ASSAY FL, TIG, IVD-CE (302382)
- Catalog Number
- 302382
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-17
- Public Version
- 4
- Public Version Date
- 2023-11-08
- Public Version Status
- Update
- Public Device Record Key
- ccb09bb2-da55-43e9-b22c-d955aecb651d
Device Description
The Aptima® Assay Fluids Kit is used with the Aptima® Assays on the Tigris® DTS® System. Use the Assay Fluids Kit according to the instructions outlined in the appropriate assay package insert and the Tigris® DTS® System Operator’s Manual.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LSL | DNA-REAGENTS, NEISSERIA | Microbiology | 866.3390 | 2 |
| MKZ | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | Microbiology | 866.3120 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61194 | Nucleic acid technique (NAT) kit IVD | A collection of reagents and other associated materials intended to be used to optimise an assay performed using a nucleic acid technique (NAT) on a clinical specimen. The kit typically consists of a silicone oil to minimize evaporation, buffered solutions for washing steps and reaction stop reagents. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045500242 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060652 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius