NATALIST OVULATION TEST MIDSTREAM 10 COUNT RH-LH-B

GUDID 00850014758042

NATALIST OVULATION TEST MIDSTREAM 10 COUNT is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 10pcs of 6mm midstreams in each box.

Runbio Biotech Co., Ltd.

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00850014758042
• NIH Device Record Key: 049c2467-599c-4dcb-8660-27691145d14c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATALIST OVULATION TEST MIDSTREAM 10 COUNT
• Version Model Number: 58042
• Catalog Number: RH-LH-B
• Company DUNS: 545868502
• Company Name: Runbio Biotech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014758042 [Primary]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-11
• Device Publish Date: 2021-01-01

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