FDA.reportPublic FDA data

Good Neighbor

Primary DI
06937579915425
Brand
Good Neighbor
Company
NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
Model
LH-M01
Device description
N/A
Published
2024-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NGETest, Luteinizing Hormone (Lh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06937579915418PrimaryGS10
06937579915425Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937579915418069375799154186937579915418
06937579915425069375799154256937579915425

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654510689
Device count
11
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937579915357Good NeighborHCG-M022024-08-26
06937579915371Good NeighborHCG-M012024-08-26
06937579915395Good NeighborHCG-M012024-08-26
06937579915418Good NeighborLH-M012024-08-26
06937579915463Foster & ThriveHCG-M012024-08-26
06937579915340Good NeighborHCG-M022024-08-26
06937579915364Good NeighborHCG-M022024-08-26
06937579915388Good NeighborHCG-M012024-08-26
06937579915401Good NeighborHCG-M012024-08-26
06937579915456Foster & ThriveHCG-M022024-08-26
06937579915470Foster & ThriveHCG-M012024-08-26
06937579912370PARAIDHCG-M042023-08-11
06937579914596EGENSLH-S2023-08-11
06937579914602EGENSLH-C2023-08-11
06937579914619EGENSLH-M2023-08-11
06937579913735sunmarkHCG-M012022-11-14
06937579913858SmilecareHCG-S32022-11-14
06937579914107RITE AIDHCG-M022023-02-03
06937579914121RITE AIDHCG-M022023-02-03
06937579914145RITE AIDHCG-M012023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974464591678One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-22
06974464591685One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-07-22
06923304611175FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611182FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611199FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611236FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611274FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06923304611281FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-07-21
06972412611690LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06972412611706LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06972412611713LittleBeginHangzhou Laihe Biotech Co.,Ltd.NGE2026-07-13
06938444982818DAVIDEquinox Biotech Co., Ltd.NGE2026-06-01
08809408864113Surearly SMARTSugentech Inc._Osong BranchNGE2026-05-08
08809408864199Surearly SMART Ovulation TestSugentech Inc._Osong BranchNGE2026-05-08
08809408864304Surearly SMART Ovulation Test Starter KitSugentech Inc._Osong BranchNGE2026-05-08
00633472602559ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602566ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
00633472602573ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-05-06
06974464591296One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591302One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
06974464591319One Step® LH Ovulation Rapid Test Dipstick (Urine)Guangzhou Decheng Biotechnology Co., LTDNGE2026-03-31
00381519194696ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHNGE2026-03-23
06952062712657Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
06952062712671Luteinizing Hormone (LH) Ovulation testANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDNGE2026-03-20
00075450847680Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
30075450847681Hy-Vee® Ovulation KitGuangzhou Decheng Biotechnology Co., LTDNGE2026-02-20
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
00045611010079SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
50045611010074SURESIGN™ Digital Ovulation Rapid TestGuangzhou Decheng Biotechnology Co., LTDNGE2026-01-28
06923304611151FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdNGE2026-01-21