Identity
- Trade Name
- Darby Dental Supply, LLC FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- TMIX PERM CEMENT CLEAR TIP FDA UDI
- Model / Reference
- 5251878 FDA UDI
- Description
- TMIX PERM CEMENT CLEAR TIP FDA UDI
Identifiers
- Catalog Number
- 5251878 FDA UDI
- Primary DI / UDI-DI
- 00889813051351 FDA UDI
- FDA Product Code
- JDZ FDA UDI
- GMDN Term
- 17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4210 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: 17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay
Darby Dental Supply, LLC by Darby Dental Supply, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay.
- GSP Neonatal 17α-OH-progesterone kit — Wallac, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Darby Dental Supply, Llc
Sources (1)
- FDA UDI 13a7d3cc-3755-4fcb-981c-ec81fb2af686 35 fields · synced May 30, 2026