PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
Device Facts
| Record ID | K000915 |
|---|---|
| Device Name | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 |
| Applicant | Humagen Fertility Diagnostics, Inc. |
| Product Code | MQK · Obstetrics/Gynecology |
| Decision Date | May 12, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6160 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
