Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. 96 Tests. FDA UDI
- Model / Reference
- F1027-96 FDA UDI
- Description
- The hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. 96 Tests. FDA UDI
Identifiers
- Catalog Number
- F1027-96 FDA UDI
- Primary DI / UDI-DI
- 00811727013255 FDA UDI
- 510(k) Number
- K991741 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA).
- Pregmate 50 Ovulation and 20 Pregnancy Test Strips — PREGMATE LLC · Class I
- Pregmate Pregnancy Test Strips (25 Count) — PREGMATE LLC · Class II
- VeriQuick — FOURSTAR GROUP INC. · Class II
- Monobind AccuBind hCG Rapid ELISA Kit - 192 Wells — MONOBIND, INC. · Class II
- R Med Pregnancy Test Strip — R MEDICAL SUPPLY INC · Class II
- Pregmate Pregnancy Test Strips (50 Count) — PREGMATE LLC · Class II
- Monobind AccuBind hCG ELISA Kit - 192 Wells — MONOBIND, INC. · Class II
- R Med Pregnancy Test Cassettes — R MEDICAL SUPPLY INC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 29bda794-8003-4b2f-a83a-c2d9f7bfbb50 37 fields · synced May 30, 2026