Identity
- Trade Name
- Status DS™ 8 card FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Status DS™ T/O/C/A//BZ/BA/TC/P card; 10 Test kit FDA UDI
- Model / Reference
- DOA-280-10-01 FDA UDI
- Description
- Status DS™ T/O/C/A//BZ/BA/TC/P card; 10 Test kit FDA UDI
Identifiers
- Catalog Number
- DOA-280-10-01 FDA UDI
- Primary DI / UDI-DI
- 10743816000440 FDA UDI
- 510(k) Number
- K991078 FDA UDI
- FDA Product Code
- LCM FDA UDIDKZ FDA UDIJXM FDA UDIDJG FDA UDIDIS FDA UDIDIO FDA UDILDJ FDA UDIMLK FDA UDI
- GMDN Term
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3170 FDA UDI862.3650 FDA UDI862.3150 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3910 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
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: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalOpiate/opiate metabolite IVD, kit, rapid ICT, clinicalBarbiturate IVD, kit, rapid ICT, clinical
Status DS™ 8 card by Princeton Biomeditech Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K991078 also covers:
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 47dc699f-d4f3-44d1-9725-8e2b9a789583 37 fields · synced May 30, 2026