Identity
- Trade Name
- Pointe G6PD Controls FDA UDI
- Generic Name
- Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control FDA UDI
- Device Name
- Pointe G6PD Controls, 2x0.5ml L1, 2x0.5ml L2, Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- G7583-CTL FDA UDI
- Description
- Pointe G6PD Controls, 2x0.5ml L1, 2x0.5ml L2, Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- G7583-CTL FDA UDI
- Primary DI / UDI-DI
- 00811727015679 FDA UDI
- 510(k) Number
- K024006 FDA UDI
- FDA Product Code
- JBF FDA UDI
- GMDN Term
- Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7360 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
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: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control
Pointe G6PD Controls by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control.
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- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- Hemoglobin G6PDH Intermediate Control — Analytical Control Systems · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · 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
Cleared under the same submission
K024006 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI b11a915d-7989-43a0-8790-bab280671f1d 37 fields · synced May 30, 2026