Identity
- Trade Name
- LSL HEALTHCARE FDA UDI
- Generic Name
- Non-evacuated urine specimen container IVD, no additive FDA UDI
- Device Name
- Specimen Collection w/ hCG Test Kit, Vacutainer & Tube FDA UDI
- Model / Reference
- 1628 FDA UDI
- Description
- Specimen Collection w/ hCG Test Kit, Vacutainer & Tube FDA UDI
Identifiers
- Catalog Number
- 1628 FDA UDI
- Primary DI / UDI-DI
- 00661392055650 FDA UDI
- FDA Product Code
- LZA FDA UDIJTW FDA UDIJHI FDA UDIFMH FDA UDI
- GMDN Term
- Non-evacuated urine specimen container IVD, no additive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI866.2900 FDA UDI862.1155 FDA UDI864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobialNon-evacuated urine specimen container IVD, no additiveEvacuated urine specimen container IVD, no additiveTotal human chorionic gonadotropin IVD, reagent
Lsl Healthcare by Lsl Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Lsl Industries, Inc.
Sources (1)
- FDA UDI 8461e72f-7741-4acc-b4f7-bccf2c45efd6 34 fields · synced Jun 7, 2026