Identity
- Trade Name
- Specimen Gate Laboratory FDA UDI
- Generic Name
- Clinical laboratory information system FDA UDI
- Device Name
- Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories. FDA UDI
- Model / Reference
- 5002-0180 FDA UDI
- Description
- Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories. FDA UDI
Identifiers
- Catalog Number
- 5002-0180 FDA UDI
- Primary DI / UDI-DI
- 06438147153312 FDA UDI
- FDA Product Code
- JQP FDA UDI
- GMDN Term
- Clinical laboratory information system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Clinical laboratory information system
Specimen Gate Laboratory by Wallac, 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
- Wallac, Inc.
Sources (1)
- FDA UDI 2566c79c-ef58-4ba8-b8b8-f6314ad926cc 34 fields · synced May 30, 2026