Identity
- Trade Name
- AccuTest-1™ FDA UDI
- Generic Name
- Allergy testing lancet FDA UDI
- Device Name
- 1 box of 12 Items ALK8002 that contains 432 single head applicators FDA UDI
- Model / Reference
- ALK8004 FDA UDI
- Description
- 1 box of 12 Items ALK8002 that contains 432 single head applicators FDA UDI
Identifiers
- Primary DI / UDI-DI
- B682ALK8004 FDA UDI
- 510(k) Number
- K172062 FDA UDI
- FDA Product Code
- LDH FDA UDI
- GMDN Term
- Allergy testing lancet FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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: Allergy testing lancet
AccuTest-1™ by Medscience Research Group, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Medscience Research Group, Inc.
Sources (1)
- FDA UDI ae409743-9c68-4f18-9476-4b5e092482e8 35 fields · synced May 30, 2026