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LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- LetsGetChecked Urine Sample Collection Kit (UACR/UACRL) FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device. FDA UDI
- Model / Reference
- UO03S FDA UDI
- Description
- A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850024881846 FDA UDI
- FDA Product Code
- OIE FDA UDI
- GMDN Term
- Urine specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
Yes
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: Urine specimen collection kit IVD
LetsGetChecked Urine Sample Collection Kit (UACR/UACRL) by Privapath Diagnostics Limited — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Urine specimen collection kit IVD.
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
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- CARDINAL HEALTH — AERO-MED LLC · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- Aero-Med — AERO-MED LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Aero-Med — AERO-MED LLC · 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
- Privapath Diagnostics Limited
Sources (1)
- FDA UDI d8c7c292-b6bd-4cd3-be9c-3a6a2577d544 33 fields · synced May 30, 2026