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Non-Invasive Prenatal Screening (NIPS) + Carrier Screening Collection Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Non-Invasive Prenatal Screening (NIPS) + Carrier Screening Collection Kit FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Model / Reference
- K-INV-N-CARRIER / 000 FDA UDI
Identifiers
- Catalog Number
- K-INV-N-CARRIER / 000 FDA UDI
- Primary DI / UDI-DI
- 00860009842236 FDA UDI
- FDA Product Code
- PQD FDA UDI
- GMDN Term
- General specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- Not 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
Non-Invasive Prenatal Screening (NIPS) + Carrier Screening Collection Kit by Labcorp Genetics — Class II — FDA UDI — listed in FDA GUDID
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 II | Pending data |
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Manufacturer
- Manufacturer
- Labcorp Genetics
Sources (1)
- FDA UDI 717017b4-be8b-4b79-ab7e-b48173e1c101 34 fields · synced May 30, 2026