International Newtech Development, Inc.
CanadaFDA applicant, unverified
- Devices
- 8
What International Newtech Development, Inc. makes
International Newtech Development, Inc. manufactures diagnostic test devices for detecting human chorionic gonadotropin (HCG) in urine and serum, including cassette and strip formats for pregnancy testing and multi-parameter urinalysis strips. Products include single-step midstream urine tests, serum HCG assays, and combo tests for both urine and serum. HCG controls are also part of the portfolio.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. These tests are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
One Step Midstream Hcg Pregnancy Test Ref K974059
Regimes: 510(k) Registry: 510(k)Mini Strip/Serum Hcg Ref K963132
Regimes: 510(k) Registry: 510(k)Ps-Unit Cassette/Serum And Urine Combo Hcg Ref K974009
Regimes: 510(k) Registry: 510(k)Urinalysis Reagent Strips (10 Parameters) Ref K993850
Regimes: 510(k) Registry: 510(k)Ministrip/ Serum And Urine Combo Hcg Test Ref K974060
Regimes: 510(k) Registry: 510(k)Ps-Unit Cassette/Serum Hcg Ref K963133
Regimes: 510(k) Registry: 510(k)Hcg Controls Ref K970176
Regimes: 510(k) Registry: 510(k)Ministrip Hcg Ref K951705
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does International Newtech Development, Inc. have in the registry?
The registry currently lists 8 devices for International Newtech Development, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list International Newtech Development, Inc.'s devices?
Among its 8 most recently registered devices, International Newtech Development, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do International Newtech Development, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for International Newtech Development, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from International Newtech Development, Inc. in the registry?
The most recently registered devices listed for International Newtech Development, Inc. include ONE STEP MIDSTREAM HCG PREGNANCY TEST, MINI STRIP/SERUM HCG, PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG and URINALYSIS REAGENT STRIPS (10 PARAMETERS).