Identity
- Trade Name
- SPOTCHECK FDA UDI
- Generic Name
- Total galactose IVD, kit, spectrophotometry FDA UDI
- Device Name
- Total Galactose Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Total Galactose (Galactose and Galactose-1-Phosphate) Levels in Neonates FDA UDI
- Model / Reference
- 81-2500-05K FDA UDI
- Description
- Total Galactose Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Total Galactose (Galactose and Galactose-1-Phosphate) Levels in Neonates FDA UDI
Identifiers
- Catalog Number
- 81-2500-05K FDA UDI
- Primary DI / UDI-DI
- 00725609000595 FDA UDI
- 510(k) Number
- K991498 FDA UDI
- FDA Product Code
- JIA FDA UDI
- GMDN Term
- Total galactose IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1310 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
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
No
FDA UDI
Category: Total galactose IVD, kit, spectrophotometry
Spotcheck by Astoria-Pacific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K991498 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 I | Pending data |
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Manufacturer
- Manufacturer
- Astoria-Pacific, Inc.
Sources (1)
- FDA UDI 06027356-1716-4769-92b0-254c190f59b1 35 fields · synced May 30, 2026