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Bifurcated Needles for Allergy Skin Testing
FDA UDIIdentity
- Trade Name
- Bifurcated Needles for Allergy Skin Testing FDA UDI
- Generic Name
- Allergy testing lancet FDA UDI
- Device Name
- Bifurcated Needles for Allergy Skin Testing FDA UDI
- Model / Reference
- PB-02000-000-00 FDA UDI
- Description
- Bifurcated Needles for Allergy Skin Testing FDA UDI
Identifiers
- Catalog Number
- PB-02000-000-00 FDA UDI
- Primary DI / UDI-DI
- 10868652000208 FDA UDI
- 510(k) Number
- K031630 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
No
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
Bifurcated Needles for Allergy Skin Testing by Roechling Medical Lancaster, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Allergy testing lancet.
- AccuTest-1™ — MEDSCIENCE RESEARCH GROUP, INC.
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- ST-9 — MEDSCIENCE RESEARCH GROUP, INC.
- AccuTest-1™ — MEDSCIENCE RESEARCH GROUP, INC.
- Prick Lancetter™ — JUBILANT HOLLISTERSTIER LLC
- Quintest® Covered Tray — JUBILANT HOLLISTERSTIER LLC
- Quintest® Multiple Skin Test Device — JUBILANT HOLLISTERSTIER LLC
- AccuTest™ Test Tray — MEDSCIENCE RESEARCH GROUP, INC.
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
- Roechling Medical Lancaster, LLC
Sources (1)
- FDA UDI 3eceacd4-3028-479e-a288-9ae365ecb263 36 fields · synced Jun 9, 2026