Identity
- Trade Name
- Procleix Tigris Lower Bay Fluids FDA UDI
- Generic Name
- Nucleic acid technique (NAT) kit IVD FDA UDI
- Device Name
- A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen. FDA UDI
- Model / Reference
- Procleix Buffer for Deactivation Fluid Kit FDA UDI
- Description
- A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859882007399 FDA UDI
- GMDN Term
- Nucleic acid technique (NAT) kit IVD FDA UDI
Classification
- 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
Yes
FDA UDI
Category: Nucleic acid technique (NAT) kit IVD
Procleix Tigris Lower Bay Fluids by Grifols Diagnostic Solutions Inc. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Grifols Diagnostic Solutions Inc.
Sources (1)
- FDA UDI 988a2d6a-7752-4f5d-8a82-4b5259d45c91 33 fields · synced Jun 9, 2026