Identity
- Trade Name
- URINE COLLECTION KIT FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- URINE(MAU) COLLECTION KIT PCP-No Internet FDA UDI
- Model / Reference
- 39 FDA UDI
- Description
- URINE(MAU) COLLECTION KIT PCP-No Internet FDA UDI
Identifiers
- Primary DI / UDI-DI
- M769MAUTEST391 FDA UDI
- FDA Product Code
- OIB 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
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: Urine specimen collection kit IVD
Urine Collection Kit by Home Access Health Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine specimen collection kit IVD.
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- SureStep Vacutainer Urine Sampling Kit — C. R. Bard, Inc. · Class I
- 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
- Home Access Health Corp.
Sources (1)
- FDA UDI b2da669f-0a1a-4c94-9c86-f5233f23327b 33 fields · synced May 30, 2026