Identity
- Trade Name
- Pointe Meprobamate Calibrator (100 ng/mL) Cutoff FDA UDI
- Generic Name
- Carisoprodol IVD, calibrator FDA UDI
- Device Name
- Pointe Meprobamate Calibrator (100 ng/mL) Cutoff 1 x 5 mL The Pointe Carisoprodol Metabolite (SOMA) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Carisoprodol Metabolite (SOMA) Reagent Set (Ref# 60-CM0740-100/60-CM0740-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-MB0746-5 FDA UDI
- Description
- Pointe Meprobamate Calibrator (100 ng/mL) Cutoff 1 x 5 mL The Pointe Carisoprodol Metabolite (SOMA) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Carisoprodol Metabolite (SOMA) Reagent Set (Ref# 60-CM0740-100/60-CM0740-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-MB0746-5 FDA UDI
- Primary DI / UDI-DI
- 00811727018410 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Carisoprodol IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carisoprodol IVD, calibrator
Pointe Meprobamate Calibrator (100 ng/mL) Cutoff by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Carisoprodol IVD, calibrator.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 3f03e2c3-e8f4-40a9-b06f-423ae9556d97 36 fields · synced Jun 6, 2026