Identity
- Trade Name
- ComforTen® 60-hole covered tray FDA UDI
- Generic Name
- Allergy testing lancet FDA UDI
- Device Name
- 60 hole test tray FDA UDI
- Model / Reference
- 8407ZA FDA UDI
- Description
- 60 hole test tray FDA UDI
Identifiers
- Catalog Number
- 8407ZA FDA UDI
- Primary DI / UDI-DI
- 00365044000066 FDA UDI
- 510(k) Number
- K953939 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
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
No
FDA UDI
Combination Product
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Allergy testing lancet
ComforTen® 60-hole covered tray by Jubilant Hollisterstier Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Allergy testing lancet.
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- AccuTest-1™ — MEDSCIENCE RESEARCH GROUP, INC.
- AccuTest™ Test Tray — MEDSCIENCE RESEARCH GROUP, INC.
- BCG Vaccine (Multiple Puncture Device) — Merck, Sharp & Dohme
- AccuTest-8™ — MEDSCIENCE RESEARCH GROUP, INC.
- AccuTest-10™ — MEDSCIENCE RESEARCH GROUP, INC.
Cleared under the same submission
K953939 also covers:
- ComforTen® 30-hole covered tray — JUBILANT HOLLISTERSTIER LLC
- ComforTen® Multiple Skin Test System — JUBILANT HOLLISTERSTIER LLC
- Prick Lancetter™ — JUBILANT HOLLISTERSTIER LLC
- Quintest® Covered Tray — JUBILANT HOLLISTERSTIER LLC
- Quintest® Multiple Skin Test Device — JUBILANT HOLLISTERSTIER LLC
- Quintip® Skin Test Device — JUBILANT HOLLISTERSTIER LLC
- Skin Test Reservoirs — JUBILANT HOLLISTERSTIER LLC
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
- Jubilant Hollisterstier Llc
Sources (1)
- FDA UDI 799b3f14-99e4-45ee-ab84-4013fe80c4fe 36 fields · synced Jun 8, 2026