Identity
- Trade Name
- Tanner Scientific® FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, reagent FDA UDI
- Device Name
- Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX FDA UDI
- Model / Reference
- TNR HCGCOMBO FDA UDI
- Description
- Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX FDA UDI
Identifiers
- Catalog Number
- TNR HCGCOMBO FDA UDI
- Primary DI / UDI-DI
- 00850011007174 FDA UDI
- 510(k) Number
- K112101 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, reagent 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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, reagent
Tanner Scientific® by Mercedes Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total human chorionic gonadotropin IVD, reagent.
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- i-STAT — Abbott Point of Care Inc. · Class II
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Mercedes Medical Llc
Sources (1)
- FDA UDI 52f62a54-7295-49ac-ab54-b50481a11af2 37 fields · synced May 30, 2026