Identity
- Trade Name
- POINTE SCIENTIFIC Ammonia/Alcohol Controls FDA UDI
- Generic Name
- Multiple clinical chemistry enzyme IVD, control FDA UDI
- Device Name
- "For in vitro diagnostic use only. The Pointe Scientific, Inc. Ammonia / Alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. (475 characters)" FDA UDI
- Model / Reference
- A7504-CTL FDA UDI
- Description
- "For in vitro diagnostic use only. The Pointe Scientific, Inc. Ammonia / Alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. (475 characters)" FDA UDI
Identifiers
- Catalog Number
- A7504-CTL FDA UDI
- Primary DI / UDI-DI
- 00811727010070 FDA UDI
- 510(k) Number
- K070504 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple clinical chemistry enzyme IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Multiple clinical chemistry enzyme IVD, control
POINTE SCIENTIFIC Ammonia/Alcohol Controls by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry enzyme IVD, control.
- FastPack® Control Kit — QUALIGEN INC. · Class I
- Internal Standard — Jeol · Class II
- Enzymer Verifier Kit — VERICHEM LABORATORIES, INC. · Class I
- Reagent Probe Wash 2 — Jeol · Class I
- ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE) — Randox Laboratories, Ltd. · Class I
- Dimension® Enzyme Verifier — Siemens Healthcare Diagnostics · Class I
- SPOTCHECK — ASTORIA-PACIFIC, INC. · Class I
- SPOTCHECK — ASTORIA-PACIFIC, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI df85d8a2-1be3-40a6-82be-b86102fb2534 37 fields · synced May 30, 2026