FDA.reportPublic FDA data

Aero-Med

Primary DI
00810010894786
Brand
Aero-Med
Company
AERO-MED, LLC
Model
LCA184A
Catalog number
LCA184A
Device description
Quantiferon TB Kit
Published
2026-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010894781PackageGS124In Commercial Distribution
00810010894786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089478150810010894781
00810010894786008100108947868100108947860810010894786

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380210891Aero-MedCA62250CA622502026-06-10
10885380213465Aero-MedCA64850CA648502026-06-10
10192253062595Aero-MedCA28600ACA28600A2022-08-26
10192253062601Aero-MedCA37125CA371252022-08-26
10192253062618Aero-MedCA37875CA378752022-08-26
10192253063561Aero-MedCA44175CA441752023-02-14
10192253063578Aero-MedCA44200CA442002023-02-14
10192253063950Aero-MedCA47175CA471752023-03-15
10192253064001Aero-MedCA48700CA487002023-10-12
10885380193255Aero-MedCA2250CCA2250C2022-07-20
10885380193262Aero-MedCA2275BCA2275B2022-07-20
10885380193538Aero-MedCA44225CA442252022-08-10
10885380193637Aero-MedCA44875CA448752022-08-24
10885380193675Aero-MedCA43775CA437752022-09-09
10885380193828Aero-MedCA44550ACA44550A2022-10-04
10885380193835Aero-MedCA44575ACA44575A2022-10-04
10885380193859Aero-MedCA45525CA455252022-10-14
10885380193965Aero-MedCA46725CA467252022-11-21
10885380194108Aero-MedCA46250CA462502022-12-15
10885380194153Aero-MedCA44900CA449002023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380210891Aero-MedAERO-MED, LLCOIB2026-06-10
10885380213465Aero-MedAERO-MED, LLCOIB2026-06-10
00810057230448SNT BiotechSARIS AND THINGS, INC.OIB2026-06-04
10885380212017Aero-MedAERO-MED, LLCOIB2026-06-04
10885380212024Aero-MedAERO-MED, LLCOIB2026-06-04
10885380211768Aero-MedAERO-MED, LLCOIB2026-05-06
10192253071504Aero-MedAERO-MED, LLCOIB2026-04-16
10192253061031Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061093Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061109Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061475Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061482Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061505Aero-MedAERO-MED, LLCOIB2026-02-20
10885380211188Aero-MedAERO-MED, LLCOIB2026-02-13
10885380210921Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210938Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210877Aero-MedAERO-MED, LLCOIB2025-12-26
10885380208935Aero-MedAERO-MED, LLCOIB2025-11-04
10885380209222Aero-MedAERO-MED, LLCOIB2025-08-26
10885380208928Aero-MedAERO-MED, LLCOIB2025-08-21
10885380208447Aero-MedAERO-MED, LLCOIB2025-06-10
10885380208461Aero-MedAERO-MED, LLCOIB2025-06-10
10194717120087Regard™ROI CPS, LLCOIB2024-10-02
10885380203657Aero-MedAERO-MED, LLCOIB2024-08-01
10885380203664Aero-MedAERO-MED, LLCOIB2024-08-01
10194717119739Regard™ROI CPS, LLCOIB2024-07-19
10194717119449Regard™ROI CPS, LLCOIB2024-05-21
10885380199165Aero-MedAERO-MED, LLCOIB2024-01-31
10885380199172Aero-MedAERO-MED, LLCOIB2024-01-31
10885380199035Aero-MedAERO-MED, LLCOIB2024-01-10