Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control FDA UDI
- Device Name
- G6PDH Control, Deficient FDA UDI
- Model / Reference
- G5888 FDA UDI
- Description
- G6PDH Control, Deficient FDA UDI
Identifiers
- Catalog Number
- G5888 FDA UDI
- Primary DI / UDI-DI
- 05391516743143 FDA UDI
- 510(k) Number
- K802568 FDA UDI
- FDA Product Code
- KHG FDA UDI
- GMDN Term
- Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7500 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
No
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
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: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control
Trinity Biotech by Clark Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control.
- Hemoglobin G6PDH Deficient Control — Analytical Control Systems · Class II
- G-6-PDH NORMAL CONTROL (G-6-PDH CONTROL N) — Randox Laboratories, Ltd. · Class I
- Audit MicroControls Control FD G6PD for Baebies FINDER — Aalto Scientific, Ltd.
- Pointe G6PD Controls — POINTE SCIENTIFIC, INC. · Class II
- Hemoglobin G6PDH Intermediate Control — Analytical Control Systems · Class II
- Hemoglobin G6PDH Normal Control — Analytical Control Systems · Class II
- G-6-PDH DEFICIENT CONTROL (G-6-PDH CONTROL D) — Randox Laboratories, Ltd. · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
Cleared under the same submission
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
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI 9f644b76-5478-4b5f-bff6-06c398fd56ed 38 fields · synced Jun 8, 2026