Humagen Fertility Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Humagen Fertility Diagnostics, Inc. makes
Humagen Fertility Diagnostics manufactures specialized laboratory tools for assisted reproductive technology, including micropipets for blastomere and polar body biopsy, NewLife culture dishes for embryo handling, and sterile Pasteur pipets for laboratory procedures. Their product line also covers intracytoplasmic sperm injection (ICSI) micropipets, holding pipets, and assisted hatching tools, as well as semen analysis kits for fertility diagnostics.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States, with its products listed in the FDA’s 510(k) database.
Catalogue
Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-Mbb, 10-Mbb-B, 10-Mpb, 10-Mpb-B Ref K012811
Regimes: 510(k) Registry: 510(k)Newlife Dish (Etched Or Non-Etched, With Or Without Lid), Models 14-52, 1452E, 1452EL, 1452l Ref K990941
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Semen Analysis Kit Ref K915229
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Humagen Fertility Diagnostics, Inc., initiated on 2007-05-08. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 8 May 2007 Z-1220-2007 Unclassified (pre-2012) Terminated Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.
Full distribution text
- 8 May 2007 Z-1220-2007 Unclassified (pre-2012) Terminated Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.
Frequently asked questions
How many devices does Humagen Fertility Diagnostics, Inc. have in the registry?
The registry currently lists 5 devices for Humagen Fertility Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Humagen Fertility Diagnostics, Inc.'s devices?
Among its 5 most recently registered devices, Humagen Fertility Diagnostics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Humagen Fertility Diagnostics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Humagen Fertility Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Humagen Fertility Diagnostics, Inc.?
FDA recall records list 1 recall initiated by Humagen Fertility Diagnostics, Inc., the most recent initiated on 8 May 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Humagen Fertility Diagnostics, Inc. in the registry?
The most recently registered devices listed for Humagen Fertility Diagnostics, Inc. include BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB, 10-MBB-B, 10-MPB, 10-MPB-B, NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L, PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 and SEMEN ANALYSIS KIT.